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Laser Gas Mixture

by Tri-Gas, Inc.

510(k) K935034

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 NumberK935034 Date14 Dec 1993ClearedStatusActive

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  • Withdrawn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.

The Laser Gas Mixture is a gas mixture for laser generation (Product Code: GEX), designed to serve as a consumable medium in laser systems for medical applications. It provides the necessary gaseous environment for laser operation, ensuring consistent performance in procedures within general and plastic surgery.

Supplied as a non-sterile, reusable gas mixture, this product is intended for use in laser devices regulated under FDA 510(k) clearance (K935034). It is classified as a Class I medical device, reflecting its low-risk designation. The mixture is supplied in standard industrial gas cylinders and must be handled according to manufacturer guidelines for safe storage and usage.

Other devices from Tri-Gas, Inc.

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 medical procedures is this gas mixture intended to support within laser systems?

    This Laser Gas Mixture from Tri-Gas, Inc. is designed specifically for use in laser systems within general and plastic surgery procedures. It serves as the consumable gaseous medium required for laser operation, ensuring stable performance during these applications.

  • Is this gas mixture reusable or single-use, and how is it packaged?

    The Laser Gas Mixture is reusable and supplied in standard industrial gas cylinders. It is not sterile, so it must be handled according to the manufacturer’s guidelines for safe storage and reuse in approved laser systems.

  • What regulatory pathway was followed for this device’s clearance, and what class designation does it hold?

    This device was cleared via a traditional 510(k) pathway (K935034) and is classified as a Class I medical device, indicating it poses minimal risk. The clearance was granted under the General, Plastic Surgery advisory committee category.

  • How should this gas mixture be stored, and are there any special handling instructions?

    Since it is supplied in industrial gas cylinders, storage must follow manufacturer guidelines for compressed gases, including proper ventilation, temperature control, and secure placement away from ignition sources. Reuse requires adherence to the manufacturer’s protocols to maintain performance and safety.