21 C.F.R. § 886.1350 Keratoscope.
Title 21 - Food and Drugs
(a) Identification. A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea. (b) The 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 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 65 FR 2320, Jan. 14, 2000]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices
§ 886.1350 Keratoscope.
