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Laser Gas Mixture

by Airgas Management, Inc.

510(k) K952301

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 NumberK952301 Date1 Jun 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  • Withdrawn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
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

Laser Gas Mixture is a device used in laser resonators for laser cutting and laser welding processes. It consists of pure gases and exact gas mixtures designed to provide protective gas for the laser process to ensure high-quality laser cutting.

The device is supplied in various modes including high- and low-pressure cylinders, portable liquid dewars, Airgas MicroBulk, and on-site tube systems. It received FDA 510(k) clearance (K952301) on June 1, 1995, and is manufactured by Airgas Management, Inc. in Kathy, TX.

Questions

AI-generated answers, 19 Sep 2026

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

  • What types of supply formats are available for the Laser Gas Mixture, and how might this affect my choice of use?

    The Laser Gas Mixture is supplied in multiple formats to accommodate different operational needs: high- and low-pressure cylinders for traditional on-site use, portable liquid dewars for mobility, Airgas MicroBulk for larger-scale applications, and on-site tube systems for continuous delivery. The choice depends on your workflow—cylinders are ideal for intermittent or smaller-scale laser cutting/welding, while dewars or tube systems suit high-volume or mobile setups.

  • Is the Laser Gas Mixture intended for use in specific laser applications, or can it be adapted for general laser cutting and welding?

    The Laser Gas Mixture is designed specifically for laser resonators used in laser cutting and laser welding processes. It provides protective gas to ensure high-quality results, but its exact composition and application depend on the manufacturer’s specifications for your particular laser system. Always verify compatibility with your equipment’s requirements.

  • How does the FDA clearance for this device impact its use in clinical or industrial settings?

    The Laser Gas Mixture received FDA 510(k) clearance (K952301) under the General, Plastic Surgery advisory committee, indicating it is deemed *substantially equivalent* to a legally marketed device. This clearance applies to its use in laser cutting and welding processes, but its suitability for specific clinical or industrial applications depends on how the end-user integrates it into their existing systems—consult your facility’s safety protocols and equipment manuals.

  • Are there different models or sizes available, and if so, how do I determine which one fits my needs?

    While the provided data does not specify exact model numbers or sizes, the Laser Gas Mixture is supplied in various formats (cylinders, dewars, MicroBulk, or tube systems). To determine the right option, consider your gas consumption rate, portability needs, and whether you require on-site or centralized delivery. Contact Airgas Management, Inc. for guidance on selecting the appropriate supply method based on your facility’s volume and workflow.