GroundRules
21 CFR 886.1120: Ophthalmic camera.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 886—OPHTHALMIC DEVICES
- Subpart B—Diagnostic Devices
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON