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) → FTF — Illuminator, Non-Remote

# FTF · Illuminator, Non-Remote

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

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

## Overview

- **Product Code:** FTF
- **Device Name:** Illuminator, Non-Remote
- **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)
- **3rd-party reviewable:** yes

## 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 |
| --- | --- | --- | --- | --- |
| [K041621](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTF/K041621.md) | LITEPORT LP100 SURGICAL ILLUMINATOR | Medical Vision Industries, Inc. | Sep 13, 2004 | SESE |
| [K840373](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTF/K840373.md) | FLEXIBLE ILLUMINATOR 10 | Suncoast Medical Manufacturers, Inc. | Apr 24, 1984 | SESE |
| [K840372](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTF/K840372.md) | FLEXIBLE ILLUMINATOR 15 | Suncoast Medical Manufacturers, Inc. | Apr 24, 1984 | SESE |
| [K840371](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTF/K840371.md) | FLEXIBLE ILLUMINATOR 5 | Suncoast Medical Manufacturers, Inc. | Apr 24, 1984 | SESE |

## Top Applicants

- Suncoast Medical Manufacturers, Inc. — 3 clearances
- Medical Vision Industries, Inc. — 1 clearance

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

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