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UltraClear Laser System

by Acclaro Corporation

510(k) K233803

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233803↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK233803 Date8 May 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233803 decided 8 May 2024 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
UltraClear Laser System (N/A)
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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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.

The UltraClear Laser System is a Fractional Laser Device (Product Code: GEX) designed for dermatological soft tissue ablation, coagulation, and resurfacing. It employs a 2910 nm laser to deliver controlled energy for skin resurfacing, collagen remodeling, and treatment across various skin types through fractional ablation.

This transportable system features a 15-inch touch screen for user-defined settings, integrated laser module, scanner drivers, and software controls. Supplied as a reusable medical device, it is cleared under FDA 510(k) K233803 and MDR, intended for use in clinical settings by trained professionals. No sterility or single-use designation is specified in the regulatory data.

From the manufacturer

Discover UltraClear® Laser, a cold ablative laser for customizable skin resurfacing, collagen remodeling, faster healing, and treatment across all skin types.

Source: ultraclearlaser.com

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Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

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