---
kind: "section"
citation: "21 C.F.R. § 886.1120"
title: "21"
number: "886.1120"
heading: "Ophthalmic camera."
url: "https://uscodex.org/cfr/21/886.1120"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 886.9](/cfr/21/886.9.md).

## Notes

### Amendments

[55 FR 48441, Nov. 20, 1990, as amended at 84 FR 71817, Dec. 30, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

### Amendments

[55 FR 48441, Nov. 20, 1990, as amended at 84 FR 71817, Dec. 30, 2019]