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M22TM Q-Switched Head

by Lumenis Be LTD 2 variants

Ref SA-1020221Be , AC-1020221Be , RSA-1020221Be , RAC-1020221Be

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011777QSWHPKU Basic UDI-DI 07290117770184UDI-DIDate25 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290117770184 UDI-DI Date2 Aug 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
M22TM Q-Switched Head EUDAMED
M22™ Q-Switched Head GUDID
Generic Name
Multi-modality skin surface treatment system
Model / Reference
SA-1020221Be EUDAMED
AC-1020221Be EUDAMED
RSA-1020221Be EUDAMED
RAC-1020221Be EUDAMED
M22™ Q-Switched Head GUDID
Primary DI / UDI-DI
07290117770184
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
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SA-1020221Be, AC-1020221Be, RSA-1020221Be, RAC-1020221Be
GUDID
M22™ Q-Switched Head
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

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

Other devices from Lumenis Be Ltd

See all devices from Lumenis Be Ltd →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No