Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4580](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4580) → FQP — Lamp, Operating-Room

# FQP · Lamp, Operating-Room

_General, Plastic Surgery · 21 CFR 878.4580 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQP

## Overview

- **Product Code:** FQP
- **Device Name:** Lamp, Operating-Room
- **Regulation:** [21 CFR 878.4580](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4580)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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.

## Classification Rationale

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.

## Special Controls

*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.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K001223](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQP/K001223.md) | ACULUX, MODEL AX3001, AX3002 | Aculux | Jun 23, 2000 | SESE |
| [K993314](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQP/K993314.md) | SYNTHES LIGHT GUIDE | Synthes (Usa) | Dec 6, 1999 | SESE |
| [K781581](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQP/K781581.md) | SURGICAL LIGHT 22 SERIES | American Sterilizer Co. | Oct 17, 1978 | SESE |
| [K770812](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQP/K770812.md) | HANDLES, LIGHT, SURGICAL, STEOILE | Sybron Corp. | May 23, 1977 | SESE |
| [K761018](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQP/K761018.md) | SURGICAL LIGHT - CHALLENGE 22 SERIES | Amsco Co. | Jan 26, 1977 | SESE |

## Top Applicants

- Aculux — 1 clearance
- American Sterilizer Co. — 1 clearance
- Amsco Co. — 1 clearance
- Sybron Corp. — 1 clearance
- Synthes (Usa) — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQP](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FQP)

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