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Stellar M22™ Q-Switched Nd:YAG Upgrade Kit

by Lumenis Be LTD 2 variants

Ref UGAC-20109600

Stellar M22 Q-Switched Nd:YAG Upgrade Kit (UGAC-20109600) is a multi-modality skin surface treatment system (EU MDR Class IIb; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Lumenis Be Ltd, registered in EUDAMED on 25 Mar 2026 (Basic UDI-DI 729011777QSWHPKU), cleared under FDA 510(k) K250809 on 16 Apr 2025 and listed in FDA GUDID since 21 Dec 2025 (UDI-DI 07290117772768), active as of 24 Oct 2026.

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

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250809

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011777QSWHPKU Basic UDI-DI 07290117772768UDI-DIDate25 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290117772768 UDI-DI Date21 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK250809 Date16 Apr 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729011777QSWHPKU registered 25 Mar 2026 Active
  • FDA 510(k) K250809 decided 16 Apr 2025 Active
  • FDA GUDID UDI-DI 07290117772768 listed 21 Dec 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K250809
  2. Listed FDA GUDID 07290117772768
  3. Registered EUDAMED 729011777QSWHPKU

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  • Withdrawn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 · GUDID

Generic name
Multi-modality skin surface treatment system
Model / reference
UGAC-20109600
Primary DI / UDI-DI
07290117772768
Basic UDI-DI
729011777QSWHPKU
510(k) Number
FDA product code
GEX
EMDN code
Z12011019 Multi–platform laser
GMDN term
Multi-modality skin surface treatment 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
Standard device
EU market of registration
Netherlands
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.

Manufacturer details

EUDAMED SRN
IL-MF-000022063
Authorised representative
Lumenis (Germany) GmbH DE-AR-000007699

Similar devices in this category

Other devices filed under MULTI–PLATFORM LASER.

Other devices from Lumenis Be Ltd

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)