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Waterlase Millennium

by Biolase Technology, Inc.

510(k) K011041

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 NumberK011041 Date3 Jul 2001ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Waterlase Millennium is a laser surgical instrument used in general and plastic surgery, and dermatology. It is designed to cut target tissues precisely and cleanly. The device is a type of carbon dioxide laser. It is intended for use in surgical procedures.

The Waterlase Millennium is supplied as a single unit and is used in a clinical setting. It has been cleared by the FDA under the 510K clearance type. The device has a product code of GEX and is classified as substantially equivalent. It is available for use in various sizes, but specific sizes are not stated.

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