21 CFR 886.1760
§ 886.1760 Ophthalmic refractometer.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 886.1760, § 886.1760 Ophthalmic refractometer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90943
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.