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PicoAlex

by Wontech Co., Ltd

510(k) K243957Ref Alexandrite Laser SystemModel PICOALEX

Active European Union and United States. Also listed in GUDID (US).

CE MDD 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) K243957↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800022304412 Basic UDI-DI 08800022304412UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800022304412 UDI-DI Date25 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK243957 Date12 Mar 2025ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800022304412 registered 18 May 2026 Active
  • FDA 510(k) K243957 decided 12 Mar 2025 Active
  • FDA GUDID UDI-DI 08800022304412 listed 25 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K243957
  2. Listed FDA GUDID 08800022304412
  3. Registered EUDAMED B-08800022304412

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Dermatological solid-state laser system
Model / reference
PICOALEX, Alexandrite Laser System
FDA applicant
Wontech Co., Ltd.
Primary DI / UDI-DI
08800022304412
Basic UDI-DI
B-08800022304412
510(k) Number
FDA product code
GEX
EMDN code
Z12011017 Neodymium surgical laser
GMDN term
Dermatological solid-state laser system
Device class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 878.4810
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device classEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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

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 PicoAlex is a pulsed dye laser device (Product Code GEX) designed for dermatological and plastic surgery applications. It delivers controlled picosecond laser pulses to target vascular lesions, pigmentation, and skin rejuvenation with precision, leveraging advanced photothermolysis technology.

Supplied as a reusable medical instrument, the PicoAlex weighs approximately 100 kg and is intended for use in clinical settings. It has received FDA 510(k) clearance under the Traditional pathway and complies with the Medical Device Directive (MDD). Storage and handling follow standard sterile or non-sterile medical device protocols as specified by the manufacturer.

Devices cleared under K243957

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K243957
UDI-DISize and differences
PICOALEX
WONTECH CO., LTD
PICOALEX08800022304412 —On the market

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)