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Models 4000, 4900, 6000, 8000, 8900, Luxus 60, 100 & 1700 - 6000

by Heraeus Lasersonics, Inc.

510(k) K902061

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 NumberK902061 Date10 Jul 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  • Withdrawn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
Models / Variants
6000
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Powered Laser Surgical Instrument, classified under the GEX product code. It is designed for surgical procedures involving laser energy, including applications in general and plastic surgery. The device utilizes Nd:YAG and CO₂ laser technologies to deliver precise, controlled energy for tissue ablation, coagulation, or vaporization.

The Models 4000, 4900, 6000, 8000, 8900, Luxus 60, 100 & 1700 are intended for reusable use in clinical settings. They hold FDA 510(k) clearance (K902061, K883379, K894164) under the General and Plastic Surgery advisory committees. Sterility and maintenance protocols must adhere to manufacturer guidelines, and compatibility with MRI environments should be verified per device specifications.

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