21 CFR 886.1120
§ 886.1120 Ophthalmic camera.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.1120, § 886.1120 Ophthalmic camera, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90895
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Full text
(a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
(b) Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, 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.