---
kind: "section"
citation: "21 C.F.R. § 878.4580"
title: "21"
number: "878.4580"
heading: "Surgical lamp."
url: "https://uscodex.org/cfr/21/878.4580"
---

# §878.4580. Surgical lamp.

- (a) **Identification.** A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.
- (b) **Classification.** Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, 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 [§ 878.9](/cfr/21/878.9.md).

## Notes

### Amendments

[53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019]

### Authority

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

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019]