StacksVerified U.S. regulatory reference

21 CFR §886.1120

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
  2. (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.