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CO2 Surgical Laser System

by Niic U.S.A., Inc.

510(k) K894074

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 NumberK894074 Date24 Aug 1989ClearedStatusActive

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  • Withdrawn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, 24 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 Co2 Surgical Laser System is a laser system used for surgical procedures. It is classified under the product code GEX. The device is manufactured by Niic U.S.A., Inc.

The Co2 Surgical Laser System is supplied in various models, including IR106 and IR204. It is used in settings such as hospitals and medical centers, including the Northern Indiana Healthcare System Veterans Affairs Medical Center. The device has received FDA 510(k) clearance, with the decision description stating that it is substantially equivalent.

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