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) → FCT — Headlight, Fiberoptic Focusing

# FCT · Headlight, Fiberoptic Focusing

_Ophthalmic · 21 CFR 886.4335 · Class 2_

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

## Overview

- **Product Code:** FCT
- **Device Name:** Headlight, Fiberoptic Focusing
- **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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K960767](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/FCT/K960767.md) | LIGHT COMMANDER | Scieran Technologies, Inc. | Aug 26, 1996 | SESE |
| [K924198](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/FCT/K924198.md) | MODIFIED SITE FIBER OPTIC MODULE | Chiron Vision Corp. | Nov 23, 1992 | SESE |
| [K883480](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/FCT/K883480.md) | MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE | Site Microsurgical Systems, Inc. | Aug 24, 1988 | SESE |
| [K802770](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/FCT/K802770.md) | FIBER OPTIC HEADLIGHT #60-0766766 | Aspen Laboratories, Inc. | Dec 11, 1980 | SESE |
| [K802769](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/FCT/K802769.md) | FIBER OPTIC HEADLIGHT #60-0765 | Aspen Laboratories, Inc. | Dec 11, 1980 | SESE |
| [K780433](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/FCT/K780433.md) | FIBER OPTIC ADJUSTABLE HEADLIGHT | Cameron-Miller, Inc. | Jun 13, 1978 | SESE |

## Top Applicants

- Aspen Laboratories, Inc. — 2 clearances
- Site Microsurgical Systems, Inc. — 1 clearance
- Scieran Technologies, Inc. — 1 clearance
- Chiron Vision Corp. — 1 clearance
- Cameron-Miller, Inc. — 1 clearance

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

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