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Picocare

by Wontech Co., Ltd

Ref Q-Switched Nd:YAG Laser SystemModel Picocare

Picocare is a device classified as Class IIb in the EU and Class II in the US made by Wontech Co., Ltd, registered in EUDAMED on 18 May 2026 (Basic UDI-DI B-08800022303200), cleared under FDA 510(k) K162755 on 12 Jun 2017 and listed in FDA GUDID since 11 Aug 2017 (UDI-DI 08800022303200), active as of 25 Oct 2026.

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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162755

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800022303200 Basic UDI-DI 08800022303200UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800022303200 UDI-DI Date11 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK162755 Date12 Jun 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800022303200 registered 18 May 2026 Active
  • FDA 510(k) K162755 decided 12 Jun 2017 Active
  • FDA GUDID UDI-DI 08800022303200 listed 11 Aug 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K162755
  2. Listed FDA GUDID 08800022303200
  3. Registered EUDAMED B-08800022303200

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  • Withdrawn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 · GUDID

Generic name
Dermatological frequency-doubled solid-state laser system
Model / reference
Picocare, Q-Switched Nd:YAG Laser System
Primary DI / UDI-DI
08800022303200
Basic UDI-DI
B-08800022303200
510(k) Number
FDA product code
GEX
EMDN code
Z12011017 Neodymium surgical laser
GMDN term
Dermatological frequency-doubled solid-state laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
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
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
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 GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dermatological frequency-doubled solid-state laser system

Similar devices in this category

Other devices filed under NEODYMIUM SURGICAL LASER.

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Properties

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