21 CFR § 886.1120 Ophthalmic Devices

§ 886.1120 Ophthalmic camera.

Current through Sep 8, 2026 · Read all of Part 886

(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]

← § 886.1100 Retinal diagnostic software device.§ 886.1140 Ophthalmic chair. →