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Gamp & Assoc. Disposable Endoocular Laser Probe

by Gamp & Assoc.

510(k) K954307

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954307 Date22 Dec 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HQB
Device Class
Class II
Regulation
21 CFR Part 886.4690
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Gamp & Assoc. Disposable Endoocular Laser Probe is an ophthalmic photocoagulator device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris. This device is designed for single-use in ophthalmic procedures requiring laser photocoagulation.

The device is supplied as a disposable probe and is regulated as a class II medical device with FDA 510(k) clearance K954307, received on September 15, 1995, and decided as substantially equivalent on December 22, 1995. It is manufactured by Gamp & Assoc. and falls under product code HQB with regulation number 886.4690. The device is intended for use in ophthalmic settings and is not specified for MRI compatibility.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Gamp & Assoc. Disposable Endoocular Laser Probe?

    This device is an ophthalmic photocoagulator designed to use energy from an extended noncoherent light source to occlude blood vessels in the retina, choroid, or iris during ophthalmic procedures requiring laser photocoagulation.

  • Is the Gamp & Assoc. Disposable Endoocular Laser Probe reusable or single-use?

    The device is designed specifically for single-use in ophthalmic procedures requiring laser photocoagulation and should not be reused to ensure patient safety and device performance.

  • What regulatory status does the Gamp & Assoc. Disposable Endoocular Laser Probe have?

    The device is regulated as a class II medical device with FDA 510(k) clearance K954307, received on September 15, 1995, and determined to be substantially equivalent on December 22, 1995.

  • How is the Gamp & Assoc. Disposable Endoocular Laser Probe supplied?

    The device is supplied as a disposable probe, meaning it comes pre-sterilized and ready for immediate use in ophthalmic settings without requiring additional preparation before procedures.