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Lasermatic Supercombo Surgical Laser System

by Lasermatic, Inc.

510(k) K903131

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 NumberK903131 Date19 Feb 1991ClearedStatusActive

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  • Withdrawn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)

Full name
Lasermatic Supercombo(Tm) Surgical Laser System
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.

This device is a surgical laser system. It is a general and plastic surgery device that has been found substantially equivalent through the FDA 510(k) process.

The system is supplied by Lasermatic, Inc. It received FDA 510(k) clearance under k-number K903131 with product code GEX. The device was cleared via traditional review on February 19, 1991, after being submitted on July 17, 1990.

Other devices from Lasermatic, Inc.

See all devices from Lasermatic, Inc. →

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 LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM used for?

    This device is a surgical laser system intended for use in general and plastic surgery procedures, as indicated by its FDA 510(k) clearance and product code GEX classification.

  • How was the LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM cleared for market?

    The device received FDA 510(k) clearance through the traditional review process after being found substantially equivalent to a predicate device, based on its submission on July 17, 1990 and clearance date of February 19, 1991.

  • What is the FDA 510(k) number for the LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM?

    The device was cleared under FDA 510(k) number K903131, which is the unique identifier assigned to this specific submission by Lasermatic, Inc.