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) → GBC — Lamp, Surgical, Incandescent

# GBC · Lamp, Surgical, Incandescent

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

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

## Overview

- **Product Code:** GBC
- **Device Name:** Lamp, Surgical, Incandescent
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K896961](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBC/K896961.md) | HALUX EXLITE MINOR SURGERY LIGHT | Jedmed Instrument Co. | Feb 22, 1990 | SESE |
| [K830610](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBC/K830610.md) | FLAT SUCTION DRAIN | Sil-Med Corp. | Mar 29, 1983 | SESE |
| [K811311](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBC/K811311.md) | SKYTRON ELITE SURGICAL TABLES | Skytron, Div. the Kmw Group, Inc. | Jun 2, 1981 | SESE |
| [K810207](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBC/K810207.md) | MINOR SURGERY LIGHT | Cavitron Corp. | Feb 13, 1981 | SESE |

## Top Applicants

- Cavitron Corp. — 1 clearance
- Jedmed Instrument Co. — 1 clearance
- Sil-Med Corp. — 1 clearance
- Skytron, Div. the Kmw Group, Inc. — 1 clearance

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

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