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) → HPQ — Headlamp, Operating, Ac-Powered

# HPQ · Headlamp, Operating, Ac-Powered

_Ophthalmic · 21 CFR 886.4335 · Class 2_

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

## Overview

- **Product Code:** HPQ
- **Device Name:** Headlamp, Operating, Ac-Powered
- **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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K952289](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPQ/K952289.md) | WELCH ALLYN FIBER OPTIC HEADLIGNT | Welch Allyn, Inc. | Jul 14, 1995 | SESE |
| [K951337](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPQ/K951337.md) | FIBER HEAD LIGHT FH-300 | Neitz Instruments Company, Ltd. | Jun 8, 1995 | SESE |
| [K861747](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPQ/K861747.md) | KEELER FIBEROPTIC HEADLAMP | Keeler Instruments, Inc. | Aug 21, 1986 | SESE |
| [K861746](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPQ/K861746.md) | KEELER DUAL LIGHTSOURCE | Keeler Instruments, Inc. | Aug 21, 1986 | SESE |
| [K822272](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPQ/K822272.md) | HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS | Kelleher Corp. | Nov 10, 1982 | SESE |

## Top Applicants

- Keeler Instruments, Inc. — 2 clearances
- Kelleher Corp. — 1 clearance
- Neitz Instruments Company, Ltd. — 1 clearance
- Welch Allyn, Inc. — 1 clearance

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

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