21 C.F.R. § 886.1120

Current through October 31, 2024
Section 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 .

21 C.F.R. §886.1120

55 FR 48441, Nov. 20, 1990, as amended at 84 FR 71817 , Dec. 30, 2019
As amended at 84 FR 71817, 12/30/2019