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21 CFR Ch. I (4–1–12 Edition) § 886.1200

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21 CFR Ch. I (4–1–12 Edition) § 886.1200 § 886.1200 21 CFR Ch. I (4–1–12 Edition) (b) Classification. Class I (general con- perforated mirror device intended to trols). The device is exempt from the inspect the interior of the eye) that premarket notification procedures in projects a bright light encompassing an subpart E of part 807 of this chapter, arc of about 30 degrees onto the fundus subject to the limitations in § 886.9. The of the eye. The center of the light bun- device is also exempt from the current dle is blocked by a black disk covering good manufacturing practice require- the fovea (the central depression of the ments of the quality system regulation macular retinae where only cones are in part 820 of this chapter, with the ex- present and blood vessels are lacking). ception of § 820.180, with respect to gen- The device is intended for use in the eral requirements concerning records, treatment of amblyopia (dimness of vi- and § 820.198, with respect to complaint sion without apparent disease of the files. eye). [52 FR 33355, Sept. 2, 1987, as amended at 53 (b) Classification. Class I for the bat- FR 35603, Sept. 14, 1988; 66 FR 38810, July 25, tery powered device. The battery pow- 2001] ered device is exempt from the pre- market notification procedures in sub- § 886.1200 Optokinetic drum. part E of part 807 of this chapter, sub- (a) Identification. An optokinetic ject to the limitations in § 886.9. Class drum is a drum-like device covered II for the AC-powered device. with alternating white and dark stripes or pictures that can be rotated on its [55 FR 48441, Nov. 20, 1990, as amended at 59 handle. The device is intended to elicit FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, and evaluate nystagmus (involuntary 2001] rapid movement of the eyeball) in pa- tients. § 886.1270 Exophthalmometer. (b) Classification. Class I (general con- (a) Identification. An trols). The device is exempt from the exophthalmometer is a device, such as premarket notification procedures in a ruler, gauge, or caliper, intended to subpart E of part 807 of this chapter, measure the degree of exophthalmos subject to the limitations in § 886.9. The (abnormal protrusion of the eyeball). device is also exempt from the current (b) Classification. Class I (general con- good manufacturing practice require- trols). The device is exempt from the ments of the quality system regulation premarket notification procedures in in part 820 of this chapter, with the ex- subpart E of part 807 of this chapter, ception of § 820.180, with respect to gen- subject to the limitations in § 886.9. eral requirements concerning records, and § 820.198, with respect to complaint [52 FR 33355, Sept. 2, 1987, as amended at 53 files. FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, 2001] [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, § 886.1290 Fixation device. 2001] (a) Identification. A fixation device is § 886.1220 Corneal electrode. an AC-powered device intended for use as a fixation target for the patient dur- (a) Identification. A corneal electrode ing ophthalmological examination. The is an AC-powered device, usually part of a special contact lens, intended to be patient directs his or her gaze so that applied directly to the cornea to pro- the visual image of the object falls on vide data showing the changes in elec- the fovea centralis (the center of the trical potential in the retina after macular retina of the eye.) electroretinography (stimulation by (b) Classification. Class I (general con- light). trols). The device is exempt from the (b) Classification. Class II. premarket notification procedures in subpart E of part 807 of this chapter, § 886.1250 Euthyscope. subject to the limitations in § 886.9. (a) Identification. A euthyscope is a [55 FR 48441, Nov. 20, 1990, as amended at 59 device that is a modified AC-powered FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, or battery-powered ophthalmoscope (a 2001] 478 VerDate Mar<15>2010 18:34 May 10, 2012 Jkt 226074 PO 00000 Frm 00488 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT ofr150 PsN: PC150.
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