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Model MC 2100 Nd:Yag Surgical Laser System

by Klinger Medical

510(k) K901340

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 NumberK901340 Date26 Jun 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  • Withdrawn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, 21 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 Model MC 2100 Nd:Yag Surgical Laser System is a surgical laser device designed for use in general and plastic surgery applications. It utilizes Nd:Yag laser technology to perform surgical procedures.

This device is supplied by Klinger Medical and has received FDA 510k clearance. It is identified by the product code GEX and reference number K901340.

Questions

AI-generated answers, 21 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 intended use of the Model MC 2100 Nd:Yag Surgical Laser System?

    This device is designed specifically for performing surgical procedures within the fields of general and plastic surgery. It utilizes Nd:Yag laser technology to facilitate these clinical applications.

  • What is the regulatory status of this surgical laser system?

    The Model MC 2100 Nd:Yag Surgical Laser System has received FDA 510k clearance. It was determined to be substantially equivalent to existing devices under the reference number K901340.

  • Who is the manufacturer of the Model MC 2100 laser system?

    The device is manufactured by Klinger Medical, located in Mission Viejo, California. They are the applicant responsible for the device submission under product code GEX.