← Product Code [HPQ](/submissions/OP/subpart-e%E2%80%94surgical-devices/HPQ) · K952289

# WELCH ALLYN FIBER OPTIC HEADLIGNT (K952289)

_Welch Allyn, Inc. · HPQ · Jul 14, 1995 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPQ/K952289

## Device Facts

- **Applicant:** Welch Allyn, Inc.
- **Product Code:** [HPQ](/submissions/OP/subpart-e%E2%80%94surgical-devices/HPQ.md)
- **Decision Date:** Jul 14, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4335
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory 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.

## 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.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPQ/K952289](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPQ/K952289)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com