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) → FSW — Light, Surgical, Endoscopic

# FSW · Light, Surgical, Endoscopic

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

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

## Overview

- **Product Code:** FSW
- **Device Name:** Light, Surgical, Endoscopic
- **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 (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K022989](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSW/K022989.md) | RADLITE TISSUE RETRACTOR SYSTEM | Genzyme Biosurgery | Nov 25, 2002 | SESE |
| [K013511](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSW/K013511.md) | XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) | Aculux, Inc. | Feb 1, 2002 | SESE |
| [K943342](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSW/K943342.md) | MEDICAM XENON LIGHT SOURCE | M.P. Video, Inc. | Oct 17, 1994 | SESE |
| [K934337](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSW/K934337.md) | CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE | Cuda Products Co. | Nov 18, 1993 | SESE |
| [K922279](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSW/K922279.md) | ILLUMINATOR IV MINOR SURGERY LIGHT | Medical Illumination, Inc. | Sep 2, 1992 | SESE |
| [K913135](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSW/K913135.md) | LM-300TWIN | Leisegang Medical, Inc. | Sep 18, 1991 | SESE |
| [K894319](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSW/K894319.md) | MEDICAL DYNAMICS LIGHT SOURCE | Medical Dynamics, Inc. | Oct 3, 1989 | SESE |
| [K870898](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSW/K870898.md) | ULTRA-LUX LIGHT SOURCE | Medline Industries, Inc. | Mar 18, 1987 | SESE |

## Top Applicants

- Aculux, Inc. — 1 clearance
- Cuda Products Co. — 1 clearance
- Genzyme Biosurgery — 1 clearance
- Leisegang Medical, Inc. — 1 clearance
- M.P. Video, Inc. — 1 clearance

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

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