21 C.F.R. § 886.1780 Retinoscope.
Title 21 - Food and Drugs
(a) Identification. A retinoscope is an AC-powered or battery-powered device intended to measure the refraction of the eye by illuminating the retina and noting the direction of movement of the light on the retinal surface and of the refraction by the eye of the emergent rays. (b) Classification. (1) Class II (special controls) for the AC-powered device. (2) Class I (general controls) for the battery-powered device. The class I battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §886.9. The battery-powered device is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180 of this chapter, with respect to general requirements concerning records, and §820.198 of this chapter, with respect to complaint files. [55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 65 FR 2320, Jan. 14, 2000]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices
§ 886.1780 Retinoscope.
