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Luxar Model LX-20 Minilase CO2 Laser

by Luxar Corp.

510(k) K896478

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 NumberK896478 Date8 Feb 1990ClearedStatusActive

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  • Withdrawn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, 23 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 Luxar Model LX-20 Minilase CO2 Laser is a medical device that utilizes carbon dioxide laser technology for surgical procedures. This device is designed for precise tissue cutting and ablation in various clinical applications.

The Luxar Model LX-20 Minilase CO2 Laser is supplied by Luxar Corp. and is authorized under FDA 510K clearance with product code GEX. The device is intended for use in general and plastic surgery settings, with specific model number LX-20. No information regarding sterility, single-use or reusable status, MRI safety, or storage conditions is provided in the device data.

Other devices from Luxar Corp.

See all devices from Luxar Corp. →

Questions

AI-generated answers, 23 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 is the Luxar Model LX-20 Minilase CO2 Laser used for?

    The Luxar Model LX-20 Minilase CO2 Laser is a medical device designed for precise tissue cutting and ablation in various clinical applications, specifically intended for use in general and plastic surgery settings.

  • What is the regulatory status of the Luxar Model LX-20 Minilase CO2 Laser?

    The Luxar Model LX-20 Minilase CO2 Laser is authorized under FDA 510K clearance with product code GEX, having been determined to be substantially equivalent to predicate devices.

  • Is the Luxar Model LX-20 Minilase CO2 Laser single-use or reusable?

    The device data does not specify whether the Luxar Model LX-20 Minilase CO2 Laser is single-use or reusable, nor does it provide information regarding sterility status or storage conditions.

  • What model number distinguishes this CO2 laser device?

    The distinguishing model number for this CO2 laser device is LX-20, which separates it from other similar products manufactured by Luxar Corp.