← Product Code [FCT](/submissions/OP/subpart-e%E2%80%94surgical-devices/FCT) · K802770

# FIBER OPTIC HEADLIGHT #60-0766766 (K802770)

_Aspen Laboratories, Inc. · FCT · Dec 11, 1980 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/FCT/K802770

## Device Facts

- **Applicant:** Aspen Laboratories, Inc.
- **Product Code:** [FCT](/submissions/OP/subpart-e%E2%80%94surgical-devices/FCT.md)
- **Decision Date:** Dec 11, 1980
- **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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/FCT/K802770](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/FCT/K802770)

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