21 CFR § 878.4580 - Surgical lamp.
---
identifier: "/us/cfr/t21/s878.4580"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.4580 - Surgical lamp."
title_number: 21
title_name: "Food and Drugs"
section_number: "878.4580"
section_name: "Surgical lamp."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "878"
part_name: "GENERAL AND PLASTIC SURGERY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 23872, June 24, 1988, unless otherwise noted."
cfr_part: "878"
---
# 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 of this chapter subject to the limitations in § 878.9.
[53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019]