Food and Drug Administration, HHS Pt. 886
§ 884.5940 Powered vaginal muscle 886.1290 Fixation device. stimulator for therapeutic use. 886.1300 Afterimage flasher. 886.1320 Fornixscope. (a) Identification. A powered vaginal 886.1330 Amsler grid. muscle stimulator is an electrically 886.1340 Haploscope. powered device designed to stimulate 886.1350 Keratoscope. directly the muscles of the vagina with 886.1360 Visual field laser instrument. pulsating electrical current. This de- 886.1375 Bagolini lens. vice is intended and labeled for thera- 886.1380 Diagnostic condensing lens. peutic use in increasing muscular tone 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens. and strength in the treatment of sexual 886.1390 Flexible diagnostic Fresnel lens. dysfunction. This generic type of de- 886.1395 Diagnostic Hruby fundus lens. vice does not include devices used to 886.1400 Maddox lens. treat urinary incontinence. 886.1405 Ophthalmic trial lens set. (b) Classification. Class III (premarket 886.1410 Ophthalmic trial lens clip. approval). 886.1415 Ophthalmic trial lens frame. (c) Date PMA or notice of completion of 886.1420 Ophthalmic lens gauge. a PDP is required. No effective date has 886.1425 Lens measuring instrument. 886.1430 Ophthalmic contact lens radius been established of the requirement for measuring device. premarket approval. See § 884.3. 886.1435 Maxwell spot. [45 FR 12684–12720, Feb. 26, 1980, as amended 886.1450 Corneal radius measuring device. at 52 FR 17741, May 11, 1987] 886.1460 Stereopsis measuring instrument. 886.1500 Headband mirror. § 884.5960 Genital vibrator for thera- 886.1510 Eye movement monitor. peutic use. 886.1570 Ophthalmoscope. 886.1605 Perimeter. (a) Identification. A genital vibrator 886.1630 AC-powered photostimulator. for therapeutic use is an electrically 886.1640 Ophthalmic preamplifier. operated device intended and labeled 886.1650 Ophthalmic bar prism. for therapeutic use in the treatment of 886.1655 Ophthalmic Fresnel prism. sexual dysfunction or as an adjunct to 886.1660 Gonioscopic prism. 886.1665 Ophthalmic rotary prism. Kegel’s exercise (tightening of the 886.1670 Ophthalmic isotope uptake probe. muscles of the pelvic floor to increase 886.1680 Ophthalmic projector. muscle tone). 886.1690 Pupillograph. (b) Classification. Class II (perform- 886.1700 Pupillometer. ance standards). 886.1750 Skiascopic rack. 886.1760 Ophthalmic refractometer. 886.1770 Manual refractor. PART 886—OPHTHALMIC DEVICES 886.1780 Retinoscope. 886.1790 Nearpoint ruler. Subpart A—General Provisions 886.1800 Schirmer strip. 886.1810 Tangent screen (campimeter). Sec. 886.1 Scope. 886.1840 Simulatan (including crossed cyl- 886.3 Effective dates of requirement for pre- inder). market approval. 886.1850 AC-powered slitlamp biomicro- 886.9 Limitations of exemptions from sec- scope. tion 510(k) of the act. 886.1860 Ophthalmic instrument stand. 886.1870 Stereoscope. Subpart B—Diagnostic Devices 886.1880 Fusion and stereoscopic target. 886.1905 Nystagmus tape. 886.1040 Ocular esthesiometer. 886.1910 Spectacle dissociation test system. 886.1050 Adaptometer (biophotometer). 886.1930 Tonometer and accessories. 886.1070 Anomaloscope. 886.1940 Tonometer sterilizer. 886.1090 Haidlinger brush. 886.1945 Transilluminator. 886.1120 Ophthalmic camera. 886.1140 Ophthalmic chair. Subpart C [Reserved] 886.1150 Visual acuity chart. 886.1160 Color vision plate illuminator. Subpart D—Prosthetic Devices 886.1170 Color vision tester. 886.1190 Distometer. 886.3100 Ophthalmic tantalum clip. 886.1200 Optokinetic drum. 886.3130 Ophthalmic conformer. 886.1220 Corneal electrode. 886.3200 Artificial eye. 886.1250 Euthyscope. 886.3300 Absorbable implant (scleral buck- 886.1270 Exophthalmometer. ling method).
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886.3320 Eye sphere implant. 886.5928 Soft (hydrophilic) contact lens care 886.3340 Extraocular orbital implant. products. 886.3400 Keratoprosthesis. 886.5933 [Reserved] 886.3600 Intraocular lens. 886.3800 Scleral shell. AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 886.3920 Eye valve implant. 360j, 371. SOURCE: 52 FR 33355, Sept. 2, 1987, unless Subpart E—Surgical Devices otherwise noted. 886.4070 Powered corneal burr. 886.4100 Radiofrequency electrosurgical cau- Subpart A—General Provisions tery apparatus. 886.4115 Thermal cautery unit. § 886.1 Scope. 886.4150 Vitreous aspiration and cutting in- strument. (a) This part sets forth the classifica- 886.4170 Cryophthalmic unit. tion of ophthalmic devices intended for 886.4230 Ophthalmic knife test drum. human use that are in commercial dis- 886.4250 Ophthalmic electrolysis unit. tribution. 886.4270 Intraocular gas. (b) The identification of a device in a 886.4275 Intraocular fluid. regulation in this part is not a precise 886.4280 Intraocular pressure measuring de- description of every device that is, or vice. 886.4300 Intraocular lens guide. will be, subject to the regulation. A 886.4335 Operating headlamp. manufacturer who submits a pre- 886.4350 Manual ophthalmic surgical instru- market notification submission for a ment. device under part 807 cannot show 886.4360 Ocular surgery irrigation device. merely that the device is accurately 886.4370 Keratome. described by the section title and iden- 886.4390 Ophthalmic laser. tification provision of a regulation in 886.4392 Nd:YAG laser for posterior this part but shall state why the device capsulotomy. 886.4400 Electronic metal locator. is substantially equivalent to other de- 886.4440 AC-powered magnet. vices, as required by § 807.87. 886.4445 Permanent magnet. (c) To avoid duplicative listings, an 886.4570 Ophthalmic surgical marker. ophthalmic device that has two or 886.4610 Ocular pressure applicator. more types of uses (e.g., used both as a 886.4670 Phacofragmentation system. diagnostic device and as a therapeutic 886.4690 Ophthalmic photocoagulator. device) is listed in one subpart only. 886.4750 Ophthalmic eye shield. 886.4770 Ophthalmic operating spectacles (d) References in this part to regu- (loupes). latory sections of the Code of Federal 886.4790 Ophthalmic sponge. Regulations are to chapter I of title 21 886.4855 Ophthalmic instrument table. unless otherwise noted.
Subpart F—Therapeutic Devices § 886.3 Effective dates of requirement for premarket approval. 886.5100 Ophthalmic beta radiation source. 886.5120 Low-power binocular loupe. A device included in this part that is 886.5420 Contact lens inserter/remover. classified into class III (premarket ap- 886.5540 Low-vision magnifier. proval) shall not be commercially dis- 886.5600 Ptosis crutch. tributed after the date shown in the 886.5800 Ophthalmic bar reader. regulation classifying the device unless 886.5810 Ophthalmic prism reader. the manufacturer has an approval 886.5820 Closed-circuit television reading system. under section 515 of the act (unless an 886.5840 Magnifying spectacles. exemption has been granted under sec- 886.5842 Spectacle frame. tion 520(g)(2) of the act). An approval 886.5844 Prescription spectacle lens. under section 515 of the act consists of 886.5850 Sunglasses (nonprescription). FDA’s issuance of an order approving 886.5870 Low-vision telescope. an application for premarket approval 886.5900 Electronic vision aid. (PMA) for the device or declaring com- 886.5910 Image intensification vision aid. pleted a product development protocol 886.5915 Optical vision aid. 886.5916 Rigid gas permeable contact lens. (PDP) for the device. 886.5918 Rigid gas permeable contact lens (a) Before FDA requires that a device care products. commercially distributed before the 886.5925 Soft (hydrophilic) contact lens. enactment date of the amendments, or
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a device that has been found substan- proval under section 515 of the act be- tially equivalent to such a device, has fore being commercially distributed. an approval under section 515 of the Accordingly, the regulation for such a act, FDA must promulgate a regula- class III transitional device states that tion under section 515(b) of the act re- as of the enactment date of the amend- quiring such approval, except as pro- ments, May 28, 1976, the device must vided in paragraphs (b) and (c) of this have an approval under section 515 of section. Such a regulation under sec- the act before commercial distribution. tion 515(b) of the act shall not be effec- tive during the grace period ending on § 886.9 Limitations of exemptions from the 90th day after its promulgation or section 510(k) of the act. on the last day of the 30th full calendar FDA’s decision to grant an exemp- month after the regulation that classi- tion from the requirement of pre- fies the device into class III is effec- market notification (section 510(k) of tive, whichever is later. See section the act) for a generic type of class I de- 501(f)(2)(B) of the act. Accordingly, un- vice is based upon the existing and rea- less an effective date of the require- sonably foreseeable characteristics of ment for premarket approval is shown commercially distributed devices with- in the regulation for a device classified in that generic type. Because FDA can- into class III in this part, the device not anticipate every change in in- may be commercially distributed with- out FDA’s issuance of an order approv- tended use or characteristic that could ing a PMA or declaring completed a significantly affect a device’s safety or PDP for the device. If FDA promul- effectiveness, manufacturers of any gates a regulation under section 515(b) commercially distributed class I device of the act requiring premarket ap- for which FDA has granted an exemp- proval for a device, section 501(f)(1)(A) tion from the requirement of pre- of the act applies to the device. market notification must still submit (b) Any new, not substantially equiv- a premarket notification to FDA before alent, device introduced into commer- introducing or delivering for introduc- cial distribution on or after May 28, tion into interstate commerce for com- 1976, including a device formerly mar- mercial distribution the device when: keted that has been substantially al- (a) The device is intended for a use tered, is classified by statute (section different from its intended use before 513(f) of the act) into class III without May 28, 1976, or the device is intended any grace period and FDA must have for a use different from the intended issued an order approving a PMA or de- use of a preamendments device to claring completed a PDP for the device which it had been determined to be before the device is commercially dis- substantially equivalent; e.g., the de- tributed unless it is reclassified. If vice is intended for a different medical FDA knows that a device being com- purpose, or the device is intended for mercially distributed may be a ‘‘new’’ lay use where the former intended use device as defined in this section be- was by health care professionals only; cause of any new intended use or other or reasons, FDA may codify the statutory (b) The modified device operates classification of the device into class using a different fundamental sci- III for such new use. Accordingly, the entific technology than that in use in regulation for such a class III device the device before May 28, 1976; e.g., a states that as of the enactment date of surgical instrument cuts tissue with a the amendments, May 28, 1976, the de- laser beam rather than with a sharp- vice must have an approval under sec- ened metal blade, or an in vitro diag- tion 515 of the act before commercial nostic device detects or identifies in- distribution. fectious agents by using a (c) A device identified in a regulation deoxyribonucleic acid (DNA) probe or in this part that is classified into class nucleic acid hybridization technology III and that is subject to the transi- rather than culture or immunoassay tional provisions of section 520(1) of the technology. act is automatically classified by stat- ute into class III and must have an ap- [53 FR 35603, Sept. 14, 1988]
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Subpart B—Diagnostic Devices tion procedures in subpart E of part 807 of this chapter. § 886.1040 Ocular esthesiometer. [55 FR 48441, Nov. 20, 1990, as amended at 59 (a) Identification. An ocular FR 63012, Dec. 7, 1994] esthesiometer is a device, such as a sin- gle-hair brush, intended to touch the § 886.1120 Opthalmic camera. cornea to assess corneal sensitivity. (a) Identification. An ophthalmic cam- (b) Classification. Class I. The device era is an AC-powered device intended is exempt from the premarket notifica- to take photographs of the eye and the tion procedures in subpart E of part 807 surrounding area. of this chapter. (b) Classification. Class II. [52 FR 33355, Sept. 2, 1987, as amended at 53 [55 FR 48441, Nov. 20, 1990] FR 35603, Sept. 14, 1988; 59 FR 63012, Dec. 7, 1994] § 886.1140 Ophthalmic chair. § 886.1050 Adaptometer (biophotom- (a) Identification. An ophthalmic eter). chair is an AC-powered or manual de- (a) Identification. An adaptometer vice with adjustable positioning in (biophotometer) is an AC-powered de- which a patient is to sit or recline dur- vice that provides a stimulating light ing ophthalmological examination or source which has various controlled in- treatment. tensities intended to measure the time (b) Classification. Class I. The AC- required for retinal adaptation (regen- powered device and the manual device eration of the visual purple) and the are exempt from the premarket notifi- minimum light threshold. cation procedures in subpart E of part (b) Classification. Class I. The device 807 of this chapter. The manual device is exempt from the premarket notifica- is also exempt from the current good tion procedures in subpart E of part 807 manufacturing practice regulations in of this chapter. part 820 of this chapter, with the excep- tion of § 820.180, with respect to general [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994] requirements concerning records, and § 820.198, with respect to complaint § 886.1070 Anomaloscope. files. (a) Identification. An anomaloscope is [55 FR 48441, Nov. 20, 1990, as amended at 59 an AC-powered device intended to test FR 63012, Dec. 7, 1994] for anomalies of color vision by dis- playing mixed spectral lines to be § 886.1150 Visual acuity chart. matched by the patient. (a) Identification. A visual acuity (b) Classification. Class I. The device chart is a device that is a chart, such is exempt from the premarket notifica- as a Snellen chart with block letters or tion procedures in subpart E of part 807 other symbols in graduated sizes, in- of this chapter. tended to test visual acuity. [55 FR 48441, Nov. 20, 1990, as amended at 59 (b) Classification. Class I. The device FR 63012, Dec. 7, 1994] is exempt from the premarket notifica- tion procedures in part 807, subpart E § 886.1090 Haidlinger brush. of this chapter. The device is exempt (a) Identification. A Haidlinger brush from the current good manufacturing is an AC-powered device that provides practice regulations in part 820 of this two conical brushlike images with chapter, with the exception of § 820.180, apexes touching which are viewed by with respect to general requirements the patient through a Nicol prism and concerning records, and § 820.198, with intended to evaluate visual function. It respect to complaint files. may include a component for measur- ing macular integrity. [52 FR 33355, Sept. 2, 1987, as amended at 53 (b) Classification. Class I. The device FR 35603, Sept. 14, 1988; 53 FR 40825, Oct. 18, 1988] is exempt from the premarket notifica-
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§ 886.1160 Color vision plate illu- § 886.1200 Optokinetic drum. minator. (a) Identification. An optokinetic (a) Identification. A color vision plate drum is a drum-like device covered illuminator is an AC-powered device with alternating white and dark stripes that is a lamp intended to properly il- or pictures that can be rotated on its luminate color vision testing plates. It handle. The device is intended to elicit may include a filter. and evaluate nystagmus (involuntary (b) Classification. Class I. The device rapid movement of the eyeball) in pa- is exempt from the premarket notifica- tients. (b) Classification. Class I. The device tion procedures in subpart E of part 807 is exempt from the premarket notifica- of this chapter. tion procedures in part 807, subpart E [55 FR 48441, Nov. 20, 1990, as amended at 59 of this chapter. The device is exempt FR 63012, Dec. 7, 1994] from the current good manufacturing practice regulations in part 820 of this § 886.1170 Color vision tester. chapter, with the exception of § 820.180, (a) Identification. A color vision tester with respect to general requirements is a device that consists of various col- concerning records, and § 820.198, with ored materials, such as colored yarns respect to complaint files. or color vision plates (multicolored [52 FR 33355, Sept. 2, 1987, as amended at 53 plates which patients with color vision FR 35604, Sept. 14, 1988] deficiency would perceive as being of one color), intended to evaluate color § 886.1220 Corneal electrode. vision. (a) Identification. A corneal electrode (b) Classification. Class I. The device is an AC-powered device, usually part is exempt from the premarket notifica- of a special contact lens, intended to be tion procedures in part 807, subpart E applied directly to the cornea to pro- of this chapter. The device is exempt vide data showing the changes in elec- from the current good manufacturing trical potential in the retina after electroretinography (stimulation by practice regulations in part 820 of this light). chapter, with the exception of § 820.180, (b) Classification. Class II. with respect to general requirements concerning records, and § 820.198, with § 886.1250 Euthyscope. respect to complaint files. (a) Identification. A euthyscope is a [52 FR 33355, Sept. 2, 1987, as amended at 53 device that is a modified AC-powered FR 35603, Sept. 14, 1988] or battery-powered ophthalmoscope (a perforated mirror device intended to § 886.1190 Distometer. inspect the interior of the eye) that (a) Identification. A distometer is a projects a bright light encompassing an device intended to measure the dis- arc of about 30 degrees onto the fundus tance between the cornea and a correc- of the eye. The center of the light bun- tive lens during refraction to help dle is blocked by a black disk covering measure the change of the visual image the fovea (the central depression of the when a lens is in place. macular retinae where only cones are present and blood vessels are lacking). (b) Classification. Class I. The device The device is intended for use in the is exempt from the premarket notifica- treatment of amblyopia (dimness of vi- tion procedures in part 807, subpart E sion without apparent disease of the of this chapter. The device is exempt eye). from the current good manufacturing (b) Classification. Class I for the bat- practice regulations in part 820 of this tery powered device. The battery pow- chapter, with the exception of § 820.180, ered device is exempt from premarket with respect to general requirements notification procedures in subpart E of concerning records, and § 820.198, with part 807 of this chapter. Class II for the respect to complaint files. AC-powered device. [52 FR 33355, Sept. 2, 1987, as amended at 53 [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 35603, Sept. 14, 1988] FR 63012, Dec. 7, 1994]
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§ 886.1270 Exophthalmometer. concerning records, and § 820.198, with respect to complaint files. (a) Identification. An exoph- thalmometer is a device, such as a [52 FR 33355, Sept. 2, 1987, as amended at 53 ruler, gauge, or caliper, intended to FR 35604, Sept. 14, 1988] measure the degree of exophthalmos (abnormal protrusion of the eyeball). § 886.1330 Amsler grid. (b) Classification. Class I. The device (a) Identification. An Amsler grid is a is exempt from the premarket notifica- device that is a series of charts with tion procedures in part 807, subpart E grids of different sizes that are held at of this chapter. 30 centimeters distance from the pa- tient and intended to rapidly detect [52 FR 33355, Sept. 2, 1987, as amended at 53 central and paracentral irregularities FR 35604, Sept. 14, 1988] in the visual field. § 886.1290 Fixation device. (b) Classification. Class I. The device is exempt from the premarket notifica- (a) Identification. A fixation device is tion procedures in part 807, subpart E an AC-powered device intended for use of this chapter. The device is exempt as a fixation target for the patient dur- from the current good manufacturing ing ophthalmological examination. The practice regulations in part 820 of this patient directs his or her gaze so that chapter, with the exception of § 820.180, the visual image of the object falls on with respect to general requirements the fovea centralis (the center of the concerning records, and § 820.198, with macular retina of the eye.) respect to complaint files. (b) Classification. Class I. The device is exempt from the premarket notifica- [52 FR 33355, Sept. 2, 1987, as amended at 53 tion procedures in subpart E of part 807 FR 35604, Sept. 14, 1988] of this chapter. § 886.1340 Haploscope. [55 FR 48441, Nov. 20, 1990, as amended at 59 (a) Identification. A haploscope is an FR 63012, Dec. 7, 1994] AC-powered device that consists of two movable viewing tubes, each contain- § 886.1300 Afterimage flasher. ing a slide carrier, a low-intensity light (a) Identification. An afterimage source for the illumination of the flasher is an AC-powered light that slides, and a high-intensity light automatically switches on and off to source for creating afterimages. The allow performance of an afterimage device is intended to measure strabis- test in which the patient indicates the mus (eye muscle imbalance), to assess positions of afterimages after the light binocular vision (use of both eyes to is off. The device is intended to deter- see), and to treat suppression and am- mine harmonious/anomalous retinal blyopia (dimness of vision without any correspondence (the condition in which apparent disease of the eye). corresponding points on the retina (b) Classification. Class I. The device have the same directional value). is exempt from the premarket notifica- (b) Classification. Class II. tion procedures in subpart E of part 807 [55 FR 48441, Nov. 20, 1990] of this chapter. [55 FR 48441, Nov. 20, 1990, as amended at 59 § 886.1320 Fornixscope. FR 63012, Dec. 7, 1994] (a) Identification. A fornixscope is a device intended to pull back and hold § 886.1350 Keratoscope. open the eyelid to aid examination of (a) Identification. A keratoscope is an the conjunctiva. AC-powered or battery-powered device (b) Classification. Class I. The device intended to measure and evaluate the is exempt from the premarket notifica- corneal curvature of the eye. Lines and tion procedures in part 807, subpart E circles within the keratoscope are used of this chapter. The device is exempt to observe the corneal reflex. This ge- from the current good manufacturing neric type of device includes the practice regulations in part 820 of this photokeratoscope which records cor- chapter, with the exception of § 820.180, neal curvature by taking photographs with respect to general requirements of the cornea.
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(b) Classification. Class I. The AC- cedure that produces an inverted or re- powered device is exempt from the pre- versed direct magnified image of the market notification procedures in sub- eye) intended to focus reflected light part E of part 807 of this chapter only from the fundus of the eye. when the device does not include com- (b) Classification. Class I. The device puter software in the unit. The bat- is exempt from the premarket notifica- tery-powered device is exempt from the tion procedures in part 807, subpart E premarket notification procedures in of this chapter. The device is exempt subpart E of part 807 of this chapter. from the current good manufacturing The battery-powered device is also ex- practice regulations in part 820 of this empt from the current good manufac- chapter, with the exception of § 820.180, turing practice regulations in part 820 with respect to general requirements of this chapter, with the exception of concerning records, and § 820.198, with § 820.180, with respect to general re- respect to complaint files. quirements concerning records, and [52 FR 33355, Sept. 2, 1987, as amended at 53 § 820.198, with respect to complaint FR 35604, Sept. 14, 1988] files. [55 FR 48441, Nov. 20, 1990, as amended at 59 § 886.1385 Polymethylmethacrylate FR 63012, Dec. 7, 1994] (PMMA) diagnostic contact lens. (a) Identification. A § 886.1360 Visual field laser instru- polymethylmethacrylate (PMMA) diag- ment. nostic contact lens is a device that is a (a) Identification. A visual field laser curved shell of PMMA intended to be instrument is an AC-powered device in- applied for a short period of time di- tended to provide visible laser radi- rectly on the globe or cornea of the eye ation that produces an interference for diagnosis or therapy of intraocular pattern on the retina to evaluate ret- abnormalities. inal function. (b) Classification. Class II. (b) Classification. Class II. § 886.1390 Flexible diagnostic Fresnel § 886.1375 Bagolini lens. lens. (a) Identification. A Bagolini lens is a (a) Identification. A flexible diag- device that consists of a plane lens con- nostic Fresnel lens is a device that is a taining almost imperceptible striations very thin lens which has its surface a that do not obscure visualization of ob- concentric series of increasingly re- jects. The device is placed in a trial fractive zones. The device is intended frame and intended to determine har- to be applied to the back of the spec- monious/anomalous retinal correspond- tacle lenses of patients with aphakia ence (a condition in which correspond- (absence of the lens of the eye). ing points on the retina have the same (b) Classification. Class I. The device directional values). is exempt from the premarket notifica- (b) Classification. Class I. The device tion procedures in part 807, subpart E is exempt from the premarket notifica- of this chapter. The device is exempt tion procedures in part 807, subpart E from the current good manufacturing of this chapter. The device is exempt practice regulations in part 820 of this from the current good manufacturing chapter, with the exception of § 820.180, practice regulations in part 820 of this with respect to general requirements chapter, with the exception of § 820.180, concerning records, and § 820.198, with with respect to general requirements respect to complaint files. concerning records, and § 820.198, with respect to complaint files. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988] [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988] § 886.1395 Diagnostic Hruby fundus lens. § 886.1380 Diagnostic condensing lens. (a) Identification. A diagnostic Hruby (a) Identification. A diagnostic con- fundus lens is a device that is a 55 diop- densing lens is a device used in bin- ter lens intended for use in the exam- ocular indirect ophthalmoscopy (a pro- ination of the vitreous body and the
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fundus of the eye under slitlamp illu- of this chapter. The device is exempt mination and magnification. from the current good manufacturing (b) Classification. Class I. The device practice regulations in part 820 of this is exempt from the premarket notifica- chapter, with the exception of § 820.180, tion procedures in part 807, subpart E with respect to general requirements of this chapter. The device is exempt concerning records, and § 820.198, with from the current good manufacturing respect to complaint files. practice regulations in part 820 of this [52 FR 33355, Sept. 2, 1987, as amended at 53 chapter, with the exception of § 820.180, FR 35604, Sept. 14, 1988] with respect to general requirements concerning records, and § 820.198, with § 886.1415 Ophthalmic trial lens frame. respect to complaint files. (a) Identification. An opthalmic trial [52 FR 33355, Sept. 2, 1987, as amended at 53 lens frame is a mechanical device in- FR 35604, Sept. 14, 1988] tended to hold trial lenses for vision testing. § 886.1400 Maddox lens. (b) Classification. Class I. The device (a) Identification. A Maddox lens is a is exempt from the premarket notifica- device that is a series of red cylinders tion procedures in part 807, subpart E that change the size, shape, and color of this chapter. The device is exempt of an image. The device is intended to from the current good manufacturing be handheld or placed in a trial frame practice regulations in part 820 of this to evaluate eye muscle dysfunction. chapter, with the exception of § 820.180, (b) Classification. Class I. The device with respect to general requirements is exempt from the premarket notifica- concerning records, and § 820.198, with tion procedures in part 807, subpart E respect to complaint files. of this chapter. The device is exempt [52 FR 33355, Sept. 2, 1987, as amended at 53 from the current good manufacturing FR 35604, Sept. 14, 1988] practice regulations in part 820 of this chapter, with the exception of § 820.180, § 886.1420 Ophthalmic lens gauge. with respect to general requirements (a) Identification. An ophthalmic lens concerning records, and § 820.198, with gauge is a calibrated device intended to respect to complaint files. manually measure the curvature of a [52 FR 33355, Sept. 2, 1987, as amended at 53 spectacle lens. FR 35604, Sept. 14, 1988] (b) Classification. Class I. The device is exempt from the premarket notifica- § 886.1405 Ophthalmic trial lens set. tion procedures in part 807, subpart E (a) Identification. An ophthalmic trial of this chapter. lens set is a device that is a set of [52 FR 33355, Sept. 2, 1987, as amended at 53 lenses of various dioptric powers in- FR 35604, Sept. 14, 1988] tended to be handheld or inserted in a trial frame for vision testing to deter- § 886.1425 Lens measuring instrument. mine refraction. (a) Identification. A lens measuring (b) Classification. Class I. The device instrument is an AC-powered device in- is exempt from the premarket notifica- tended to measure the power of lenses, tion procedures in subpart E of part 807 prisms, and their centers (e.g., of this chapter. lensometer). [52 FR 33355, Sept. 2, 1987, as amended at 61 (b) Classification. Class I. The device FR 1124, Jan. 16, 1996] is exempt from the premarket notifica- tion procedures in subpart E of part 807 § 886.1410 Ophthalmic trial lens clip. of this chapter. (a) Identification. An ophthalmic trial [55 FR 48442, Nov. 20, 1990, as amended at 59 lens clip is a device intended to hold FR 63013, Dec. 7, 1994] prisms, spheres, cylinders, or occluders on a trial frame or spectacles for vision § 886.1430 Ophthalmic contact lens ra- testing. dius measuring device. (b) Classification. Class I. The device (a) Identification. An ophthalmic con- is exempt from the premarket notifica- tact lens radius measuring device is an tion procedures in part 807, subpart E AC-powered device that is a microscope
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and dial gauge intended to measure the § 886.1500 Headband mirror. radius of a contact lens. (b) Classification. Class I. The device (a) Identification. A headband mirror is exempt from the premarket notifica- is a device intended to be strapped to tion procedures in subpart E of part 807 the head of the user to reflect light for of this chapter. use in examination of the eye. (b) Classification. Class I. The device [55 FR 48442, Nov. 20, 1990, as amended at 59 is exempt from the premarket notifica- FR 63013, Dec. 7, 1994] tion procedures in part 807, subpart E § 886.1435 Maxwell spot. of this chapter. The device is exempt (a) Identification. A Maxwell spot is from the current good manufacturing an AC-powered device that is a light practice regulations in part 820 of this source with a red and blue filter in- chapter, with the exception of § 820.180, tended to test macular function. with respect to general requirements (b) Classification. Class I. The device concerning records, and § 820.198, with is exempt from the premarket notifica- respect to complaint files. tion procedures in subpart E of part 807 [52 FR 33355, Sept. 2, 1987, as amended at 53 of this chapter. FR 35605, Sept. 14, 1988] [55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994] § 886.1510 Eye movement monitor. § 886.1450 Corneal radius measuring (a) Identification. An eye movement device. monitor is an AC-powered device with an electrode intended to measure and (a) Identification. A corneal radius measuring device is an AC-powered de- record ocular movements. vice intended to measure corneal size (b) Classification. Class II. by superimposing the image of the cor- nea on a scale at the focal length of the § 886.1570 Ophthalmoscope. lens of a small, hand held, single tube (a) Identification. An ophthalmoscope penscope or eye gauge magnifier. is an AC-powered or battery-powered (b) Classification. Class I. The device device containing illumination and is exempt from the premarket notifica- viewing optics intended to examine the tion procedures in subpart E of part 807 media (cornea, aqueous, lens, and vit- of this chapter only when the device reous) and the retina of the eye. does not include computer software in (b) Classification. Class II. the unit or topographers. [55 FR 48442, Nov. 20, 1990, as amended at 59 § 886.1605 Perimeter. FR 63013, Dec. 7, 1994] (a) Identification. A perimeter is an AC-powered or manual device intended § 886.1460 Stereopsis measuring in- strument. to determine the extent of the periph- eral visual field of a patient. The de- (a) Identification. A stereopsis meas- vice projects light on various points of uring instrument is a device intended a curved surface, and the patient indi- to measure depth perception by illu- mination of objects placed on different cates whether he or she sees the light. planes. (b) Classification. Class I. The manual (b) Classification. Class I. The device device is exempt from the premarket is exempt from the premarket notifica- notification procedures in part 807, sub- tion procedures in part 807, subpart E part E of this chapter, and it is also ex- of this chapter. The device is exempt empt from the current good manufac- from the current good manufacturing turing practice regulations in part 820 practice regulations in part 820 of this of this chapter, with the exception of chapter, with the exception of § 820.180, § 820.180, with respect to general re- with respect to general requirements quirements concerning records, and concerning records, and § 820.198, with § 820.198 with respect to the complaint respect to complaint files. files. [52 FR 33355, Sept. 2, 1987, as amended at 53 [55 FR 48442, Nov. 20, 1990] FR 35605, Sept. 14, 1988]
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§ 886.1630 AC-powered tion procedures in part 807, subpart E photostimulator. of this chapter. The device also is ex- (a) Identification. An AC-powered empt from the current good manufac- photostimulator is an AC-powered de- turing practice regulations in part 820 vice intended to provide light stimulus of this chapter, with the exception of which allows measurement of retinal § 820.180, with respect to general re- or visual function by perceptual or quirements concerning records, and electrical methods (e.g., stroboscope). § 820.198, with respect to complaint (b) Classification. Class II. files. [52 FR 33355, Sept. 2, 1987, as amended at 53 § 886.1640 Ophthalmic preamplifier. FR 35605, Sept. 14, 1988] (a) Identification. An ophthalmic pre- amplifier is an AC-powered or battery- § 886.1660 Gonioscopic prism. powered device intended to amplify (a) Identification. A gonioscopic prism electrical signals from the eye in is a device that is a prism intended to electroretinography (recording retinal be placed on the eye to study the ante- action currents from the surface of the rior chamber. The device may have an- eyeball after stimulation by light), gled mirrors to facilitate visualization electrooculography (testing for retinal of anatomical features. dysfunction by comparing the standing (b) Classification. Class I. The device potential in the front and the back of is exempt from the premarket notifica- the eyeball), and electromyography tion procedures in subpart E of part 807 (recording electrical currents gen- of this chapter. erated in active muscle). (b) Classification. Class II. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 59 FR 63013, Dec. 7, § 886.1650 Ophthalmic bar prism. 1994] (a) Identification. An ophthalmic bar § 886.1665 Ophthalmic rotary prism. prism is a device that is a bar com- posed of fused prisms of gradually in- (a) Identification. An ophthalmic ro- creasing strengths intended to measure tary prism is a device with various latent and manifest strabismus (eye prismatic powers intended to be muscle deviation) or the power of fu- handheld and used to measure ocular sion of a patient’s eyes. deviation in patients with latent or (b) Classification. Class I. The device manifest strabismus (eye muscle devi- is exempt from the premarket notifica- ation). tion procedures in part 807, subpart E (b) Classification. Class I. The device of this chapter. The device also is ex- is exempt from the premarket notifica- empt from the current good manufac- tion procedures in part 807, subpart E turing practice regulations in part 820 of this chapter. The device also is ex- of this chapter, with the exception of empt from the current good manufac- § 820.180, with respect to general re- turing practice regulations in part 820 quirements concerning records, and of this chapter, with the exception of § 820.198, with respect to complaint § 820.180, with respect to general re- files. quirements concerning records, and § 820.198, with respect to complaint [52 FR 33355, Sept. 2, 1987, as amended at 53 files. FR 35605, Sept. 14, 1988] [52 FR 33355, Sept. 2, 1987, as amended at 53 § 886.1655 Ophthalmic Fresnel prism. FR 35605, Sept. 14, 1988] (a) Identification. An ophthalmic Fresnel prism is a device that is a thin § 886.1670 Ophthalmic isotope uptake plastic sheet with embossed rulings probe. which provides the optical effect of a (a) Identification. An ophthalmic iso- prism. The device is intended to be ap- tope uptake probe is an AC-powered de- plied to spectacle lenses to give a pris- vice intended to measure, by a probe matic effect. which is placed in close proximity to (b) Classification. Class I. The device the eye, the uptake of a radioisotope is exempt from the premarket notifica- (phosphorus 32) by tumors to detect
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tumor masses on, around, or within the tion procedures in subpart E of part 807 eye. of this chapter. (b) Classification. Class II. [52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996] § 886.1680 Ophthalmic projector. (a) Identification. An ophthalmic pro- § 886.1760 Ophthalmic refractometer. jector is an AC-powered device in- (a) Identification. An ophthalmic re- tended to project an image on a screen fractometer is an automatic AC-pow- for vision testing. ered device that consists of a fixation (b) Classification. Class I. The device system, a measurement and recording is exempt from the premarket notifica- system, and an alignment system in- tion procedures in subpart E of part 807 tended to measure the refractive power of this chapter. of the eye by measuring light reflexes [55 FR 48442, Nov. 20, 1990, as amended at 59 from the retina. FR 63013, Dec. 7, 1994] (b) Classification. Class I. The device is exempt from the premarket notifica- § 886.1690 Pupillograph. tion procedures in subpart E of part 807 (a) Identification. A pupillograph is an of this chapter. AC-powered device intended to meas- [52 FR 33355, Sept. 2, 1987, as amended at 61 ure the pupil of the eye by reflected FR 1124, Jan. 16, 1996] light and record the responses of the pupil. § 886.1770 Manual refractor. (b) Classification. Class I. The device (a) Identification. A manual refractor is exempt from the premarket notifica- is a device that is a set of lenses of tion procedures in subpart E of part 807 varous dioptric powers intended to of this chapter. measure the refractive error of the eye. [55 FR 48442, Nov. 20, 1990, as amended at 59 (b) Classification. Class I. The device FR 63013, Dec. 7, 1994] is exempt from the premarket notifica- tion procedures in part 807, subpart E § 886.1700 Pupillometer. of this chapter. The device also is ex- (a) Identification. A pupillometer is an empt from the current good manufac- AC-powered or manual device intended turing practice regulations in part 820 to measure by reflected light the width of this chapter, with the exception of or diameter of the pupil of the eye. § 820.180, with respect to general re- (b) Classification. Class I. The AC- quirements concerning records, and powered device and the manual device § 820.198, with respect to complaint are exempt from the premarket notifi- files. cation procedures in subpart E of part [52 FR 33355, Sept. 2, 1987, as amended at 53 807 of this chapter. The manual device FR 35605, Sept. 14, 1988] is also exempt from the current good manufacturing practice regulations in § 886.1780 Retinoscope. part 820 of this chapter, with the excep- (a) Identification. A retinoscope is an tion of § 820.180, with respect to general AC-powered or battery-powered device requirements concerning records, and intended to measure the refraction of § 820.198, with respect to complaint the eye by illuminating the retina and files. noting the direction of movement of [55 FR 48442, Nov. 20, 1990, as amended at 59 the light on the retinal surface and of FR 63013, Dec. 7, 1994] the refraction by the eye of the emer- gent rays. § 886.1750 Skiascopic rack. (b) Classification. Class I for the bat- (a) Identification. A skiascopic rack is tery-powered device. Class II for the a device that is a rack and a set of at- AC-powered device. The battery-pow- tached ophthalmic lenses of various ered device is exempt from the current dioptric strengths intended as an aid in good manufacturing practice regula- refraction. tions in part 820 of this chapter, with (b) Classification. Class I. The device the exception of § 820.180, with respect is exempt from the premarket notifica- to general requirements concerning
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records, and § 820.198, with respect to market notification procedures in sub- complaint files. part E of part 807 of this chapter. The battery-powered device is also exempt [55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990] from the current good manufacturing practice regulations in part 820 of this § 886.1790 Nearpoint ruler. chapter, with the exception of § 820.180, with respect to general requirements (a) Identification. A nearpoint ruler is concerning records, and § 820.198, with a device calibrated in centimeters in- respect to complaint files. tended to measure the nearpoint of convergence (the point to which the [55 FR 48442, Nov. 20, 1990, as amended at 59 visual lines are directed when conver- FR 63013, Dec. 7, 1994] gence is at its maximum). (b) Classification. Class I. The device § 886.1840 Simulatan (including crossed cylinder). is exempt from the premarket notifica- tion procedures in part 807, subpart E (a) Identification. A simulatan (in- of this chapter. The device also is ex- cluding crossed cylinder) is a device empt from the current good manufac- that is a set of pairs of cylinder lenses turing practice regulations in part 820 that provides various equal plus and of this chapter, with the exception of minus refractive strengths. The lenses § 820.180, with respect to general re- are arranged so that the user can ex- quirements concerning records, and change the positions of plus and minus § 820.198, with respect to complaint cylinder lenses of equal strengths. The files. device is intended for subjective refrac- tion (refraction in which the patient [52 FR 33355, Sept. 2, 1987, as amended at 53 judges whether a given object is clearly FR 35605, Sept. 14, 1988; 53 FR 40825, Oct. 18, in focus, as the examiner uses different 1988] lenses). § 886.1800 Schirmer strip. (b) Classification. Class I. The device is exempt from the premarket notifica- (a) Identification. A Schirmer strip is tion procedures in part 807, subpart E a device made of filter paper or similar of this chapter. The device also is ex- material intended to be inserted under empt from the current good manufac- a patient’s lower eyelid to stimulate turing practice regulations in part 820 and evaluate formation of tears. of this chapter, with the exception of (b) Classification. Class I. If the device § 820.180, with respect to general re- is made of the same materials that quirements concerning records, and were used in the device before May 28, § 820.198, with respect to complaint 1976, the device is exempt from the pre- files. market notification procedures in part 807, subpart E of this chapter. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988] [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988] § 886.1850 AC-powered slitlamp bio- microscope. § 886.1810 Tangent screen (campim- (a) Identification. An AC-powered eter). slitlamp biomicroscope is an AC-pow- (a) Identification. A tangent screen ered device that is a microscope in- (campimeter) is an AC-powered or bat- tended for use in eye examination that tery-powered device that is a large projects into a patient’s eye through a square cloth chart with a central mark control diaphragm a thin, intense beam of fixation intended to map on a flat of light. surface the central 30 degrees of a pa- (b) Classification. Class II. tient’s visual field. This generic type of device includes projection tangent § 886.1860 Ophthalmic instrument screens, target tangent screens and stand. targets, felt tangent screens, and (a) Identification. An ophthalmic in- stereo campimeters. strument stand is an AC-powered or (b) Classification. Class I. The AC- nonpowered device intended to store powered device and the battery-pow- ophthalmic instruments in a readily ered device are exempt from the pre- accessible position.
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(b) Classification. Class I. The AC- § 820.198, with respect to complaint powered device and the battery-pow- files. ered device are exempt from the pre- [52 FR 33355, Sept. 2, 1987, as amended at 53 market notification procedures in sub- FR 35606, Sept. 14, 1988] part E of part 807 of this chapter. The battery-powered device is also exempt § 886.1905 Nystagmus tape. from the current good manufacturing (a) Identification. Nystagmus tape is a practice regulations in part 820 of this device that is a long, narrow strip of chapter, with the exception of § 820.180, fabric or other flexible material on with respect to general requirements which a series of objects are printed. concerning records, and § 820.198, with The device is intended to be moved respect to complaint files. across a patient’s field of vision to elic- it optokinetic nystagmus (abnormal [55 FR 48442, Nov. 20, 1990, as amended at 59 and irregular eye movements) and to FR 63013, Dec. 7, 1994] test for blindness. § 886.1870 Stereoscope. (b) Classification. Class I. The device is exempt from the premarket notifica- (a) Identification. A stereoscope is an tion procedures in part 807, subpart E AC-powered or battery-powered device of this chapter. The device also is ex- that combines the images of two simi- empt from the current good manufac- lar objects to produce a three-dimen- turing practice regulations in part 820 sional appearance of solidity and relief. of this chapter, with the exception of It is intended to measure the angle of § 820.180, with respect to general re- strabismus (eye muscle deviation), quirements concerning records, and evaluate binocular vision (usage of § 820.198, with respect to complaint both eyes to see), and guide a patient’s files. corrective exercises of eye muscles. [52 FR 33355, Sept. 2, 1987, as amended at 53 (b) Classification. Class I. The AC- FR 35606, Sept. 14, 1988] powered device and the battery-pow- ered device are exempt from the pre- § 886.1910 Spectacle dissociation test market notification procedures in sub- system. part E of part 807 of this chapter. The (a) Identification. A spectacle disso- battery-powered device is also exempt ciation test system is an AC-powered from the current good manufacturing or battery-powered device, such as a practice regulations in part 820 of this Lancaster test system, that consists of chapter, with the exception of § 820.180, a light source and various filters, usu- with respect to general requirements ally red or green filters, intended to concerning records, and § 820.198, with subjectively measure imbalance of ocu- respect to complaint files. lar muscles. (b) Classification. Class I. The AC- [55 FR 48442, Nov. 20, 1990, as amended at 59 powered device and the battery-pow- FR 63013, Dec. 7, 1994] ered device are exempt from the pre- market notification procedures in sub- § 886.1880 Fusion and stereoscopic tar- part E of part 807 of this chapter. The get. battery-powered device is also exempt (a) Identification. A fusion and stereo- from the current good manufacturing scopic target is a device intended for practice regulations in part 820 of this use as a viewing object with a stereo- chapter, with the exception of § 820.180, scope (§ 886.1870). with respect to general requirements (b) Classification. Class I. The device concerning records, and § 820.198, with is exempt from the premarket notifica- respect to complaint files. tion procedures in part 807, subpart E [55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. of this chapter. The device also is ex- 17, 1990, as amended at 59 FR 63013, Dec. 7, empt from the current good manufac- 1994] turing practice regulations in part 820 of this chapter, with the exception of § 886.1930 Tonometer and accessories. § 820.180, with respect to general re- (a) Identification. A tonometer and ac- quirements concerning records, and cessories is a manual device intended
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to measure intraocular pressure by ap- during the healing process following plying a known force on the globe of surgery. the eye and measuring the amount of (b) Classification. Class II. indentation produced (Schiotz type) or to measure intraocular tension by § 886.3200 Artificial eye. applanation (applying a small flat disk (a) Identification. An artificial eye is to the cornea). Accessories for the de- a device resembling the anterior por- vice may include a tonometer cali- tion of the eye, usually made of glass brator or a tonograph recording sys- or plastic, intended to be inserted in a tem. The device is intended for use in patient’s eye socket anterior to an or- the diagnosis of glaucoma. bital implant, or the eviscerated eye- (b) Classification. Class II. ball, for cosmetic purposes. The device is not intended to be implanted. § 886.1940 Tonometer sterilizer. (b) Classification. Class I. The device (a) Identification. A tonometer steri- is exempt from the premarket notifica- lizer is an AC-powered device intended tion procedures in subpart E of part 807 to heat sterilize a tonometer (a device of this chapter if the device is made used to measure intraocular pressure). from the same materials, has the same (b) Classification. Class I. chemical composition, and uses the [55 FR 48443, Nov. 20, 1990] same manufacturing processes as cur- rently legally marketed devices. § 886.1945 Transilluminator. [61 FR 1124, Jan. 16, 1996] (a) Identification. A transilluminator is an AC-powered or battery-powered § 886.3300 Absorbable implant (scleral device that is a light source intended buckling method). to transmit light through tissues to aid (a) Identification. An absorbable im- examination of patients. plant (scleral buckling method) is a de- (b) Classification. Class I for the bat- vice intended to be implanted on the tery-powered device. Class II for the sclera to aid retinal reattachment. AC-powered device. The battery-pow- (b) Classification. Class II. ered Class I device is exempt from the premarket notification procedures in § 886.3320 Eye sphere implant. subpart E of part 807 of this chapter. (a) Identification. An eye sphere im- [55 FR 48443, Nov. 20, 1990, as amended at 59 plant is a device intended to be im- FR 63013, Dec. 7, 1994] planted in the eyeball to occupy space following the removal of the contents Subpart C [Reserved] of the eyeball with the sclera left in- tact. Subpart D—Prosthetic Devices (b) Classification. Class II. § 886.3100 Ophthalmic tantalum clip. § 886.3340 Extraocular orbital implant. (a) Identification. An ophthalmic tan- (a) Identification. An extraocular or- talum clip is a malleable metallic de- bital implant is a nonabsorbable device vice intended to be implanted perma- intended to be implanted during scleral nently or temporarily to bring to- surgery for buckling or building up the gether the edges of a wound to aid floor of the eye, usually in conjunction healing or prevent bleeding from small with retinal reattachment. Injectable blood vessels in the eye. substances are excluded. (b) Classification. Class II. (b) Classification. Class II.
§ 886.3130 Ophthalmic conformer. § 886.3400 Keratoprosthesis. (a) Identification. An ophthalmic con- (a) Identification. A keratoprosthesis former is a device usually made of is a device made of plastic intended to molded plastic intended to be inserted be implanted to replace the central temporarily between the eyeball and area of an opacified natural cornea of eyelid to maintain space in the orbital the eye to maintain or restore sight. cavity and prevent closure or adhesions (b) Classification. Class III.
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(c) Date PMA or notice of completion of AC-powered or battery-powered device a PDP is required. No effective date has intended for use during ocular surgery been established of the requirement for to coagulate tissue or arrest bleeding premarket approval. See § 886.3. by a high frequency electric current. (b) Classification. Class II. § 886.3600 Intraocular lens. (a) Identification. An intraocular lens § 886.4115 Thermal cautery unit. is a device made of materials such as (a) Identification. A thermal cautery glass or plastic intended to be im- unit is an AC-powered or battery-pow- planted to replace the natural lens of ered device intended for use during oc- an eye. ular surgery to coagulate tissue or ar- (b) Classification. Class III. rest bleeding by heat conducted (c) Date PMA or notice of completion of through a wire tip. a PDP is required. As of May 28, 1976, an (b) Classification. Class II. approval under section 515 of the act is required before this device may be § 886.4150 Vitreous aspiration and cut- commercially distributed. See § 886.3. ting instrument. § 886.3800 Scleral shell. (a) Identification. A vitreous aspira- tion and cutting instrument is an elec- (a) Identification. A scleral shell is a trically powered device, which may use device made of glass or plastic that is ultrasound, intended to remove vit- intended to be inserted for short time reous matter from the vitreous cavity periods over the cornea and proximal- or remove a crystalline lens. cornea sclera for cosmetic or recon- structive purposes. An artificial eye is (b) Classification. Class II. usually painted on the device. The de- § 886.4170 Cryophthalmic unit. vice is not intended to be implanted. (b) Classification. Class II. (a) Identification. A cryophthalmic unit is a device that is a probe with a § 886.3920 Eye valve implant. small tip that becomes extremely cold (a) Identification. An eye valve im- through the controlled use of a refrig- plant is a one-way, pressure-sensitive, erant or gas. The device may be AC- valve-like device intended to be im- powered. The device is intended to re- planted to normalize intraocular pres- move cataracts by the formation of an sure. The device may be used in the adherent ice ball in the lens, to freeze treatment of glaucoma. the eye and adjunct parts for surgical (b) Classification. Class III. removal of scars, and to freeze tumors. (c) Date PMA or notice of completion of (b) Classification. Class II. a PDP is required. No effective date has been established of the requirement for § 886.4230 Ophthalmic knife test drum. premarket approval. See § 886.3. (a) Identification. An ophthalmic knife test drum is a device intended to Subpart E—Surgical Devices test the keenness of ophthalmic sur- gical knives to determine whether re- § 886.4070 Powered corneal burr. sharpening is needed. (a) Identification. A powered corneal (b) Classification. Class I. The device burr is an AC-powered or battery-pow- is exempt from the premarket notifica- ered device that is a motor and drilling tion procedures in part 807, subpart E tool intended to remove rust rings of this chapter. The device also is ex- from the cornea of the eye. empt from the current good manufac- (b) Classification. Class I. turing practice regulations in part 820 of this chapter, with the exception of [55 FR 48443, Nov. 20, 1990; 55 FR 51799, Dec. § 820.180, with respect to general re- 17, 1990] quirements concerning records, and § 886.4100 Radiofrequency § 820.198, with respect to complaint electrosurgical cautery apparatus. files. (a) Identification. A radiofrequency [52 FR 33355, Sept. 2, 1987, as amended at 53 electrosurgical cautery apparatus is an FR 35606, Sept. 14, 1988]
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§ 886.4250 Ophthalmic electrolysis (c) Date PMA or notice of completion of unit. PDP is required. As of May 28, 1976, an (a) Identification. An ophthalmic elec- approval under section 515 of the act is trolysis unit is an AC-powered or bat- required before this device may be tery-powered device intended to de- commercially distributed. See § 886.3. stroy ocular hair follicles by applying a galvanic electrical current. § 886.4300 Intraocular lens guide. (b) Classification. Class I for the bat- (a) Identification. An intraocular lens tery-powered device. Class II for the guide is a device intended to be in- AC-powered device. The battery-pow- serted into the eye during surgery to ered Class I device is exempt from the direct the insertion of an intraocular premarket notification procedures in lens and be removed after insertion is subpart E of part 807 of this chapter. completed. [55 FR 48443, Nov. 20, 1990, as amended at 59 (b) Classification. Class I. FR 63013, Dec. 7, 1994] § 886.4335 Operating headlamp. § 886.4270 Intraocular gas. (a) Identification. An operating (a) Identification. An intraocular gas headlamp is an AC-powered or battery- is a device consisting of a gaseous fluid powered device intended to be worn on intended to be introduced into the eye the user’s head to provide a light to place pressure on a detached retina. source to aid visualization during sur- (b) Classification. Class III. gical, diagnostic, or therapeutic proce- (c) Date PMA or notice of completion of dures. a PDP is required. As of May 28, 1976, an (b) Classification. Class I for the bat- approval under section 515 of the act is tery-powered device. Class II for the required before this device may be commercially distributed. See § 886.3. AC-powered device. The battery pow- ered-device is exempt from the pre- § 886.4275 Intraocular fluid. market notification procedures in part 807, subpart E of this chapter. (a) Identification. An intraocular fluid is a device consisting of a nongaseous [55 FR 48443, Nov. 20, 1990] fluid intended to be introduced into the eye to aid performance of surgery, such § 886.4350 Manual ophthalmic surgical as to maintain anterior chamber depth, instrument. preserve tissue integrity, protect tissue (a) Identification. A manual ophthal- from surgical trauma, or function as a mic surgical instrument is a nonpow- tamponade during retinal reattach- ered, handheld device intended to aid ment. or perform ophthalmic surgical proce- (b) Classification. Class III. dures. This generic type of device in- (c) Date PMA or notice of completion of cludes the manual corneal burr, oph- a PDP is required. As of May 28, 1976, an thalmic caliper, ophthalmic cannula, approval under section 515 of the act is eyelid clamp, ophthalmic muscle required before this device may be clamp, iris retractor clip, orbital com- commercially distributed. See § 886.3. pressor, ophthalmic curette, § 886.4280 Intraocular pressure meas- cystotome, orbital depressor, lach- uring device. rymal dilator, erisophake, expressor, (a) Identification. An intraocular pres- ophthalmic forcep, ophthalmic hook, sure measuring device is a manual or sphere introducer, ophthalmic knife, AC-powered device intended to meas- ophthalmic suturing needle, lachrymal ure intraocular pressure. Also included probe, trabeculotomy probe, cornea- are any devices found by FDA to be sclera punch, ophthalmic retractor, substantially equivalent to such de- ophthalmic ring (Flieringa), lachrymal vices. Accessories for the device may sac rongeur, ophthalmic scissors, include calibrators or recorders. The enucleating snare, ophthalmic spatula, device is intended for use in the diag- ophthalmic specula, ophthalmic spoon, nosis of glaucoma. ophthalmic spud, trabeculotome or (b) Classification. Class III. ophthalmic manual trephine.
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(b) Classification. Class I. The device (b) Classification. Class II. is exempt from the premarket notifica- [53 FR 38947, Oct. 4, 1988] tion procedures in subpart E of part 807 of this chapter. § 886.4400 Electronic metal locator. [52 FR 33355, Sept. 2, 1987, as amended at 53 (a) Identification. An electronic metal FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, locator is an AC-powered device with 1994; 60 FR 15872, Mar. 28, 1995] probes intended to locate metallic for- eign bodies in the eye or eye socket. § 886.4360 Ocular surgery irrigation (b) Classification. Class II. device. (a) Identification. An ocular surgery § 886.4440 AC-powered magnet. irrigation device is a device intended (a) Identification. An AC-powered to be suspended over the ocular area magnet is an AC-powered device that during ophthalmic surgery to deliver generates a magnetic field intended to continuous, controlled irrigation to the find and remove metallic foreign bodies surgical field. from eye tissue. (b) Classification. Class I. The device (b) Classification. Class II. is exempt from the premarket notifica- tion procedures in subpart E of part 807 § 886.4445 Permanent magnet. of this chapter. (a) Identification. A permanent mag- net is a nonelectric device that gen- [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, erates a magnetic field intended to find 1994] and remove metallic foreign bodies from eye tissue. § 886.4370 Keratome. (b) Classification. Class I. The device is exempt from the premarket notifica- (a) Identification. A keratome is an tion procedures in part 807, subpart E AC-powered or battery-powered device of this chapter. The device also is ex- intended to shave tissue from sections empt from the current good manufac- of the cornea for a lamellar (partial turing practice regulations in part 820 thickness) transplant. of this chapter, with the exception of (b) Classification. Class I. § 820.180, with respect to general re- [55 FR 48443, Nov. 20, 1990] quirements concerning records, and § 820.198, with respect to complaint § 886.4390 Ophthalmic laser. files. (a) Identification. An ophthalmic laser [52 FR 33355, Sept. 2, 1987, as amended at 53 is an AC-powered device intended to FR 35606, Sept. 14, 1988] coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser § 886.4570 Ophthalmic surgical mark- beam. er. (b) Classification. Class II. (a) Identification. An ophthalmic sur- gical marker is a device intended to § 886.4392 Nd:YAG laser for posterior mark by use of ink, dye, or indentation capsulotomy. the location of ocular or scleral sur- (a) Identification. The Nd:YAG laser gical manipulation. for posterior capsulotomy consists of a (b) Classification. Class I. The device mode-locked or Q-switched solid state is exempt from the premarket notifica- Nd:YAG laser intended for posterior tion procedures in subpart E of part 807 capsulotomy, which generates short of this chapter. pulse, low energy, high power, coherent [52 FR 33355, Sept. 2, 1987, as amended at 53 optical radiation. When the laser out- FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, put is combined with focusing optics, 1994] the high irradiance at the target causes tissue disruption via optical § 886.4610 Ocular pressure applicator. breakdown. A visible aiming system is (a) Identification. An ocular pressure utilized to target the invisible Nd:YAG applicator is a manual device that con- laser radiation on or in close proximity sists of a sphygmomanometer-type to the target tissue. squeeze bulb, a dial indicator, a band,
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and bellows, intended to apply pressure § 820.180, with respect to general re- on the eye in preparation for ophthal- quirements concerning records, and mic surgery. § 820.198, with respect to complaint (b) Classification. Class II. files. § 886.4670 Phacofragmentation system. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988] (a) Identification. A phacofrag- mentation system is an AC-powered de- § 886.4790 Ophthalmic sponge. vice with a fragmenting needle in- tended for use in cataract surgery to (a) Identification. An ophthalmic disrupt a cataract with ultrasound and sponge is a device that is an absorbant extract the cataract. sponge, pad, or spear made of folded (b) Classification. Class II. gauze, cotton, cellulose, or other mate- rial intended to absorb fluids from the § 886.4690 Ophthalmic operative field in ophthalmic surgery. photocoagulator. (b) Classification. Class II. (a) Identification. An ophthalmic photocoagulator is an AC-powered de- § 886.4855 Ophthalmic instrument vice intended to use the energy from an table. extended noncoherent light source to (a) Identification. An ophthalmic in- occlude blood vessels of the retina, strument table is an AC-powered or choroid, or iris. manual device on which ophthalmic in- (b) Classification. Class II. struments are intended to be placed. § 886.4750 Ophthalmic eye shield. (b) Classification. Class I. The AC- powered device and the manual device (a) Identification. An ophthalmic eye are exempt from the premarket notifi- shield is a device that consists of a plastic or aluminum eye covering in- cation procedures in subpart E of part tended to protect the eye or retain 807 of this chapter. The manual device dressing materials in place. is also exempt from the current good (b) Classification. Class I. The device manufacturing practice regulations in is exempt from the premarket notifica- part 820 of this chapter, with the excep- tion procedures in subpart E of part 807 tion of § 820.180, with respect to general of this chapter. The device also is ex- requirements concerning records, and empt from the current good manufac- § 820.198, with respect to complaint turing practice regulations in part 820 files. of this chapter, with the exception of [55 FR 48443, Nov. 20, 1990, as amended at 59 § 820.180, with respect to general re- FR 63014, Dec. 7, 1994] quirements concerning records, and § 820.198, with respect to complaint files. Subpart F—Therapeutic Devices [52 FR 33355, Sept. 2, 1987, as amended at 59 § 886.5100 Ophthalmic beta radiation FR 63014, Dec. 7, 1994] source.
§ 886.4770 Ophthalmic operating spec- (a) Identification. An ophthalmic beta tacles (loupes). radiation source is a device intended to apply superficial radiation to benign (a) Ophthalmic operat- Identification. and malignant ocular growths. ing spectacles (loupes) are devices that (b) Classification. Class II. consist of convex lenses or lens sys- tems intended to be worn by a surgeon § 886.5120 Low-power binocular loupe. to magnify the surgical site during ophthalmic surgery. (a) Identification. A low-power bin- (b) Classification. Class I. The device ocular loupe is a device that consists of is exempt from the premarket notifica- two eyepieces, each with a lens or lens tion procedures in part 807, subpart E system, intended for medical purposes of this chapter. The device also is ex- to magnify the appearance of objects. empt from the current good manufac- (b) Classification. Class I. The device turing practice regulations in part 820 is exempt from the premarket notifica- of this chapter, with the exception of tion procedures in part 807, subpart E
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of this chapter. The device also is ex- of this chapter, with the exception of empt from the current good manufac- § 820.180, with respect to general re- turing practice regulations in part 820 quirements concerning records, and of this chapter, with the exception of § 820.198, with respect to complaint § 820.180, with respect to general re- files. quirements concerning records, and § 820.198, with respect to complaint [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988] files. [52 FR 33355, Sept. 2, 1987, as amended at 53 § 886.5800 Ophthalmic bar reader. FR 35607, Sept. 14, 1988] (a) Identification. An ophthalmic bar § 886.5420 Contact lens inserter/re- reader is a device that consists of a mover. magnifying lens intended for use by a patient who has impaired vision. The (a) Identification. A contact lens device is placed directly onto reading inserter/remover is a handheld device material to magnify print. intended to insert or remove contact (b) Classification. Class I. The device lenses by surface adhesion or suction. is exempt from the premarket notifica- (b) Classification. Class I. The device tion procedures in part 807, subpart E is exempt from the premarket notifica- of this chapter. The device also is ex- tion procedures in part 807, subpart E empt from the current good manufac- of this chapter. turing practice regulations in part 820 [52 FR 33355, Sept. 2, 1987, as amended at 53 of this chapter, with the exception of FR 35607, Sept. 14, 1988] § 820.180, with respect to general re- quirements concerning records, and § 886.5540 Low-vision magnifier. § 820.198, with respect to complaint (a) Identification. A low-vision mag- files. nifier is a device that consists of a magnifying lens intended for use by a [52 FR 33355, Sept. 2, 1987, as amended at 53 patient who has impaired vision. The FR 35607, Sept. 14, 1988] device may be held in the hand or at- § 886.5810 Ophthalmic prism reader. tached to spectacles. (b) Classification. Class I. The device (a) Identification. An ophthalmic is exempt from the premarket notifica- prism reader is a device intended for tion procedures in part 807, subpart E use by a patient who is in a supine po- of this chapter. The device also is ex- sition to change the angle of print to empt from the current good manufac- aid reading. turing practice regulations in part 820 (b) Classification. Class I. The device of this chapter, with the exception of is exempt from the premarket notifica- § 820.180, with respect to general re- tion procedures in part 807, subpart E quirements concerning records, and of this chapter. The device also is ex- § 820.198, with respect to complaint empt from the current good manufac- files. turing practice regulations in part 820 of this chapter, with the exception of [52 FR 33355, Sept. 2, 1987, as amended at 53 § 820.180, with respect to general re- FR 35607, Sept. 14, 1988] quirements concerning records, and § 886.5600 Ptosis crutch. § 820.198, with respect to complaint files. (a) Identification. A ptosis crutch is a device intended to be mounted on the [52 FR 33355, Sept. 2, 1987, as amended at 53 spectacles of a patient who has ptosis FR 35607, Sept. 14, 1988] (drooping of the upper eyelid as a re- sult of faulty development or paralysis) § 886.5820 Closed-circuit television to hold the upper eyelid open. reading system. (b) Classification. Class I. The device (a) Identification. A closed-circuit tel- is exempt from the premarket notifica- evision reading system is a device that tion procedures in part 807, subpart E consists of a lens, video camera, and of this chapter. The device also is ex- video monitor that is intended for use empt from the current good manufac- by a patient who has subnormal vision turing practice regulations in part 820 to magnify reading material.
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(b) Classification. Class I. The AC- spectacle frames or clips with absorb- powered device is exempt from the pre- ing, reflective, tinted, polarizing, or market notification procedures in sub- photosensitized lenses intended to be part E of part 807 of this chapter. worn by a person to protect the eyes [55 FR 48443, Nov. 20, 1990, as amended at 59 from bright sunlight but not to provide FR 63014, Dec. 7, 1994] refractive corrections. This device is usually available over-the-counter. § 886.5840 Magnifying spectacles. (b) Classification. Class I. (a) Identification. Magnifying spec- tacles are devices that consist of spec- § 886.5870 Low-vision telescope. tacle frames with convex lenses in- (a) Identification. A low-vision tele- tended to be worn by a patient who has scope is a device that consists of an ar- impaired vision to enlarge images. rangement of lenses or mirrors in- (b) Classification. Class I. The device tended for use by a patient who has im- is exempt from the premarket notifica- paired vision to increase the apparent tion procedures in subpart E of part 807 size of objects. This generic type of de- of this chapter. vice includes handheld or spectacle [52 FR 33355, Sept. 2, 1987, as amended at 53 telescopes. FR 35607, Sept. 14, 1988; 59 FR 63014, Dec. 7, (b) Classification. Class I. The device 1994] is exempt from the premarket notifica- § 886.5842 Spectacle frame. tion procedures in part 807, subpart E of this chapter. The device also is ex- (a) Identification. A spectacle frame is empt from the current good manufac- a device made of metal or plastic in- tended to hold prescription spectacle turing practice regulations in part 820 lenses worn by a patient to correct re- of this chapter, with the exception of fractive errors. § 820.180, with respect to general re- (b) Classification. Class I. The device quirements concerning records, and is exempt from the premarket notifica- § 820.198, with respect to complaint tion procedures in subpart E of part 807 files. of this chapter. [52 FR 33355, Sept. 2, 1987, as amended at 53 [52 FR 33355, Sept. 2, 1987, as amended at 59 FR 35607, Sept. 14, 1988] FR 63014, Dec. 7, 1994] § 886.5900 Electronic vision aid. § 886.5844 Prescription spectacle lens. (a) Identification. An electronic vision (a) Identification. A prescription spec- aid is an AC-powered or battery-pow- tacle lens is a glass or plastic device ered device that consists of an elec- that is a lens intended to be worn by a tronic sensor/transducer intended for patient in a spectacle frame to provide use by a patient who has impaired vi- refractive corrections in accordance sion or blindness to translate visual with a prescription for the patient. The images of objects into tactile or audi- device may be modified to protect the tory signals. eyes from bright sunlight (i.e., pre- (b) Classification. Class I. The device scription sunglasses). Prescription sun- is exempt from the premarket notifica- glass lenses may be reflective, tinted, tion procedures in subpart E of part 807 polarizing, or photosensitized. of this chapter. (b) Classification. Class I. The device is exempt from the premarket notifica- [55 FR 48443, Nov. 20, 1990, as amended at 59 tion procedures in subpart E of part 807 FR 63014, Dec. 7, 1994] of this chapter. § 886.5910 Image intensification vision [52 FR 33355, Sept. 2, 1987, as amended at 53 aid. FR 35607, Sept. 14, 1988; 59 FR 63014, Dec. 7, 1994] (a) Identification. An image inten- sification vision aid is a battery-pow- § 886.5850 Sunglasses (nonprescrip- ered device intended for use by a pa- tion). tient who has limited dark adaptation (a) Identification. Sunglasses (non- or impaired vision to amplify ambient prescription) are devices that consist of light.
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(b) Classification. Class I. The device paragraph (b)(2) of this section may be is exempt from the premarket notifica- commercially distributed. See § 886.3. tion procedures in part 807, subpart E of this chapter. The device also is ex- [52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994] empt from the current good manufac- turing practice regulations in part 820 § 886.5918 Rigid gas permeable contact of this chapter, with the exception of lens care products. § 820.180, with respect to general re- quirements concerning records, and (a) Identification. A rigid gas per- § 820.198, with respect to complaint meable contact lens care product is a files. device intended for use in the cleaning, conditioning, rinsing, lubricating/re- [52 FR 33355, Sept. 2, 1987, as amended at 53 wetting, or storing of a rigid gas per- FR 35607, Sept. 14, 1988] meable contact lens. This includes all solutions and tablets used together § 886.5915 Optical vision aid. with rigid gas permeable contact (a) Identification. An optical vision lenses. aid is a device that consists of a mag- (b) Classification. Class II (Special nifying lens with an accompanying AC- Controls) Guidance Document: ‘‘Guid- powered or battery-powered light ance for Industry Premarket Notifica- source intended for use by a patient tion (510(k)) Guidance Document for who has impaired vision to increase the Contact Lens Care Products.’’ apparent size of object detail. (b) Classification. Class I. The AC- [62 FR 30987, June 6, 1997] powered device and the battery-pow- § 886.5925 Soft (hydrophilic) contact ered device are exempt from the pre- lens. market notification procedures in sub- part E of part 807 of this chapter. The (a) Identification. A soft (hydrophilic) battery-powered device is also exempt contact lens is a device intended to be from the current good manufacturing worn directly against the cornea and practice regulations in part 820 of this adjacent limbal and scleral areas of the chapter, with the exception of § 820.180, eye to correct vision conditions or act with respect to general requirements as a therapeutic bandage. The device is concerning records, and § 820.198, with made of various polymer materials the respect to complaint files. main polymer molecules of which ab- sorb or attract a certain volume (per- [55 FR 48443, Nov. 20, 1990, as amended at 59 centage) of water. FR 63014, Dec. 7, 1994] (b) Classification. (1) Class II if the de- § 886.5916 Rigid gas permeable contact vice is intended for daily wear only. lens. (2) Class III if the device is intended for extended wear. (a) Identification. A rigid gas per- (c) Date PMA or notice of completion of meable contact lens is a device in- a PDP is required. As of May 28, 1976, an tended to be worn directly against the cornea of the eye to correct vision con- approval under section 515 of the act is ditions. The device is made of various required before a device described in materials, such as cellulose acetate bu- paragraph (b)(2) of this section may be tyrate, polyacrylate-silicone, or sili- commercially distributed. See § 886.3. cone elastomers, whose main polymer [52 FR 33355, Sept. 2, 1987, as amended at 59 molecules generally do not absorb or FR 10284, Mar. 4, 1994] attract water. (b) Classification. (1) Class II if the de- § 886.5928 Soft (hydrophilic) contact vice is intended for daily wear only. lens care products. (2) Class III if the device is intended (a) Identification. A soft (hydrophilic) for extended wear. contact lens care product is a device (c) Date PMA or notice of completion of intended for use in the cleaning, rins- a PDP is required. As of May 28, 1976, an ing, disinfecting, lubricating/rewetting, approval under section 515 of the act is or storing of a soft (hydrophilic) con- required before a device described in tact lens. This includes all solutions
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and tablets used together with soft (hy- 888.3170 Elbow joint radial (hemi-elbow) drophilic) contact lenses and heat dis- polymer prosthesis. infecting units intended to disinfect a 888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. soft (hydrophilic) contact lens by 888.3200 Finger joint metal/metal con- means of heat. strained uncemented prosthesis. (b) Classification. Class II (Special 888.3210 Finger joint metal/metal con- Controls) Guidance Document: ‘‘Guid- strained cemented prosthesis. ance for Industry Premarket Notifica- 888.3220 Finger joint metal/polymer con- tion (510(k)) Guidance Document for strained cemented prosthesis. Contact Lens Care Products.’’ 888.3230 Finger joint polymer constrained prosthesis. [62 FR 30988, June 6, 1997] 888.3300 Hip joint metal constrained ce- mented or uncemented prosthesis. § 886.5933 [Reserved] 888.3310 Hip joint metal/polymer con- strained cemented or uncemented pros- thesis. PART 888—ORTHOPEDIC DEVICES 888.3320 Hip joint metal/metal semi-con- strained, with a cemented acetabular Subpart A—General Provisions component, prosthesis. 888.3330 Hip joint metal/metal semi-con- Sec. 888.1 Scope. strained, with an uncemented acetabular 888.3 Effective dates of requirement for pre- component, prosthesis. 888.3340 Hip joint metal/composite semi- market approval. 888.5 Resurfacing technique. constrained cemented prosthesis. 888.3350 Hip joint metal/polymer semi-con- 888.6 Degree of constraint. 888.9 Limitations of exemptions from sec- strained cemented prosthesis. 888.3353 Hip joint metal/ceramic/polymer tion 510(k) of the act. semi-constrained cemented or nonporous Subpart B—Diagnostic Devices uncemented prosthesis. 888.3358 Hip joint metal/polymer/metal 888.1100 Arthroscope. semi–constrained porous–coated 888.1240 AC-powered dynamometer. uncemented prosthesis. 888.1250 Nonpowered dynamometer. 888.3360 Hip joint femoral (hemi-hip) metal- 888.1500 Goniometer. lic cemented or uncemented prosthesis. 888.1520 Nonpowered goniometer. 888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis. Subpart C [Reserved] 888.3380 Hip joint femoral (hemi-hip) trun- nion-bearing metal/polyacetal cemented Subpart D—Prosthetic Devices prosthesis. 888.3390 Hip joint femoral (hemi-hip) metal/ 888.3000 Bone cap. polymer cemented or uncemented pros- 888.3010 Bone fixation cerclage. thesis. 888.3015 Bone heterograft. 888.3400 Hip joint femoral (hemi-hip) metal- 888.3020 Intramedullary fixation rod. lic resurfacing prosthesis. 888.3025 Passive tendon prosthesis. 888.3410 Hip joint metal/polymer semi-con- 888.3027 Polymethylmethacrylate (PMMA) strained resurfacing cemented pros- bone cement. thesis. 888.3030 Single/multiple component metallic 888.3480 Knee joint femorotibial metallic bone fixation appliances and accessories. constrained cemented prosthesis. 888.3040 Smooth or threaded metallic bone 888.3490 Knee joint femorotibial metal/com- fixation fastener. posite non-constrained cemented pros- 888.3050 Spinal interlaminal fixation ortho- thesis. sis. 888.3500 Knee joint femorotibial metal/com- 888.3060 Spinal intervertebral body fixation posite semi-constrained cemented pros- orthosis. thesis. 888.3100 Ankle joint metal/composite semi- 888.3510 Knee joint femorotibial metal/poly- constrained cemented prosthesis. mer constrained cemented prosthesis. 888.3110 Ankle joint metal/polymer semi- 888.3520 Knee joint femorotibial metal/poly- constrained cemented prosthesis. mer non-constrained cemented pros- 888.3120 Ankle joint metal/polymer non-con- thesis. strained cemented prosthesis. 888.3530 Knee joint femorotibial metal/poly- 888.3150 Elbow joint metal/metal or metal/ mer semi-constrained cemented pros- polymer constrained cemented pros- thesis. thesis. 888.3540 Knee joint patellofemoral polymer/ 888.3160 Elbow joint metal/polymer semi- metal semi-constrained cemented pros- constrained cemented prosthesis. thesis.
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