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MODELS 4000, 4900, 6000, 8000, 8900, LUXUS 60, 100, 1700

by Heraeus Lasersonics, Inc.

510(k) K902148

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 NumberK902148 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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 device is a powered laser surgical instrument, including models 4000, 4900, 6000, 8000, 8900, LUXUS 60, 100, and 1700, designed for use in medical procedures. It is classified as a Class II device with special controls under FDA 510(k) clearance.

The device is supplied as a single-use or reusable unit, depending on the model, and is intended for use in general and plastic surgery. It is not MRI safe, and storage requirements are not specified in the provided data.

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