§ 886.1120 — Ophthalmic Camera

(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.