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) → HJE — Lamp, Fluorescein, Ac-Powered

# HJE · Lamp, Fluorescein, Ac-Powered

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

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

## Overview

- **Product Code:** HJE
- **Device Name:** Lamp, Fluorescein, Ac-Powered
- **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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K922348](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HJE/K922348.md) | VALTRAC(R) INTRODUCER FORCEP | American Cyanamid Co. | Jun 9, 1992 | SESE |
| [K802291](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HJE/K802291.md) | FLUORESCENT SUN LAMP FIXTURE | Strato-Ray Co. | Oct 31, 1980 | SESE |
| [K781698](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HJE/K781698.md) | EXAMINER 10 | American Sterilizer Co. | Nov 3, 1978 | SESE |

## Top Applicants

- American Cyanamid Co. — 1 clearance
- American Sterilizer Co. — 1 clearance
- Strato-Ray Co. — 1 clearance

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

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