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Niic Laser System

by Niic U.S.A., Inc.

510(k) K896988

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 NumberK896988 Date23 Jan 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  • Withdrawn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, 26 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 NIIC LASER SYSTEM is a powered laser surgical instrument used in medical procedures. It is classified under product code GEX and is intended for use in general and plastic surgery applications.

The device is supplied by Niic U.S.A., Inc. and received FDA 510(k) clearance on January 23, 1990. It is a Class II device with a traditional clearance type and was reviewed by the General and Plastic Surgery advisory committee. The system is available in various models including the MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM.

Other devices from Niic U.S.A., Inc.

See all devices from Niic U.S.A., Inc. →

Questions

AI-generated answers, 26 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 NIIC LASER SYSTEM used for?

    The NIIC LASER SYSTEM is a powered laser surgical instrument intended for use in general and plastic surgery applications.

  • What models of the NIIC LASER SYSTEM are available?

    The system is available in various models, including the MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM.

  • How was the NIIC LASER SYSTEM cleared for market?

    The NIIC LASER SYSTEM received FDA 510(k) clearance on January 23, 1990, under the traditional clearance type.

  • Who is the manufacturer of the NIIC LASER SYSTEM?

    The NIIC LASER SYSTEM is supplied by Niic U.S.A., Inc., located in Redwood City, California.