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) → FSQ — Light, Surgical, Instrument

# FSQ · Light, Surgical, Instrument

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

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

## Overview

- **Product Code:** FSQ
- **Device Name:** Light, Surgical, Instrument
- **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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K932139](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSQ/K932139.md) | LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT | Aaron Medical Industries | Jul 30, 1993 | SESE |
| [K930686](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSQ/K930686.md) | MIDMARK SURGICAL LIGHTING SYSTEMS | Midmark Corp. | Jul 30, 1993 | SESE |
| [K922409](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSQ/K922409.md) | ALM ILLUMINATOR SERIES LIGHT SYSTEM | Alm Surgical Equipment, Inc. | Jan 12, 1993 | SESE |
| [K921848](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSQ/K921848.md) | BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT | Alm Surgical Equipment, Inc. | Oct 1, 1992 | SESE |
| [K803067](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSQ/K803067.md) | SURG-FLEX 10 LIGHT | Medical Products Development, Inc. | Feb 26, 1981 | SESE |
| [K810019](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSQ/K810019.md) | SURG-FLEX 15 SURGICAL LIGHT | Medical Products Development, Inc. | Jan 23, 1981 | SESE |
| [K810018](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSQ/K810018.md) | SURG-FLEX 5 SURGICAL LIGHT | Medical Products Development, Inc. | Jan 23, 1981 | SESE |

## Top Applicants

- Medical Products Development, Inc. — 3 clearances
- Alm Surgical Equipment, Inc. — 2 clearances
- Midmark Corp. — 1 clearance
- Aaron Medical Industries — 1 clearance

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

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