Ophthalmic camera.

21 C.F.R. § 886.1120
in effectEffective: 2024-07-01
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(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.

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