21 CFR § 886.1120
Ophthalmic camera
June 25, 2020
(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.
[55 FR 48441, Nov. 20, 1990, as amended at 84 FR 71817, Dec. 30, 2019]
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