Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart B - Diagnostic Devices / § 886.1760 Ophthalmic refractometer.
§ 886.1760 Ophthalmic refractometer.
(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.