Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4335](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4335) → FSR — Light, Headband, Surgical

# FSR · Light, Headband, Surgical

_Ophthalmic · 21 CFR 886.4335 · Class 2_

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

## Overview

- **Product Code:** FSR
- **Device Name:** Light, Headband, Surgical
- **Regulation:** [21 CFR 886.4335](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4335)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.

## Classification Rationale

(1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

## Special Controls

*Classification.* (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K110528](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/FSR/K110528.md) | INTEGRA LED SURGICAL HEADLIGHT SYSTEM | Integra LifeSciences Corporation | May 11, 2011 | SESE |
| [K031549](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/FSR/K031549.md) | SOLID STATE LAMP [LED] HEADLIGHT | Welch Allyn, Inc. | Aug 11, 2003 | SESE |
| [K031548](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/FSR/K031548.md) | LED HEADLIGHT | Welch Allyn, Inc. | Aug 11, 2003 | SESE |
| [K994362](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/FSR/K994362.md) | HEADLAMP HL2000. | Angiolaz, Inc. | May 11, 2000 | SESE |

## Top Applicants

- Welch Allyn, Inc. — 2 clearances
- Integra LifeSciences Corporation — 1 clearance
- Angiolaz, Inc. — 1 clearance

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

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