21 C.F.R. § 886.1760 Ophthalmic refractometer.
Title 21 - Food and Drugs
(a) Identification. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §886.9. [52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38812, July 25, 2001]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices
§ 886.1760 Ophthalmic refractometer.