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Omniguide BeamPath CO2 Mark I Laser Beam Delivery

by Omniguide Communications, Inc.

510(k) K050541

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 NumberK050541 Date9 May 2005ClearedStatusActive

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  • Withdrawn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
HQF
Device Class
Class II
Regulation
21 CFR Part 886.4390
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 Omniguide BeamPath Co2 Mark I Laser Beam Delivery is a laser beam delivery system, consisting of an adapter and a fiber assembly, utilizing a photonic bandgap reflector lining a hollow core to guide 10.6 um Co2 laser energy for the incision, excision, ablation, vaporization and coagulation of body soft tissues. It is classified as a Laser, Ophthalmic device.

The device is supplied with a product code of HQF and is regulated under regulation number 886.4390. It has been assigned a device class of 2 and has received FDA 510K authorization, with a decision date of 2005-05-09. The device is intended for use in ophthalmic medical specialties.

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 Omniguide BeamPath Co2 Mark I Laser Beam Delivery system used for?

    The Omniguide BeamPath Co2 Mark I Laser Beam Delivery system is used for the incision, excision, ablation, vaporization, and coagulation of body soft tissues in ophthalmic medical specialties.

  • Is the Omniguide BeamPath Co2 Mark I Laser Beam Delivery system supplied sterile?

    The device data does not specify if the Omniguide BeamPath Co2 Mark I Laser Beam Delivery system is supplied sterile, but it is intended for use in ophthalmic medical specialties where sterility is typically crucial.

  • What is the regulatory classification of the Omniguide BeamPath Co2 Mark I Laser Beam Delivery system?

    The Omniguide BeamPath Co2 Mark I Laser Beam Delivery system is classified as a Laser, Ophthalmic device, with a device class of 2, and is regulated under regulation number 886.4390.