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LightSheer® QUATTRO™

by Lumenis Be LTD

Ref GA-1140000Be

LightSheer QUATTRO (GA-1140000Be) is a dermatological diode laser 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 729011777LSUW), cleared under FDA 510(k) K170179 on 18 Sep 2017 and listed in FDA GUDID since 10 Aug 2023 (UDI-DI 07290117770030), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170179

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/MDR EUDAMED Number729011777LSUW Basic UDI-DI 07290117770030UDI-DIDate25 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290117770030 UDI-DI Date10 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170179 Date18 Sep 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729011777LSUW registered 25 Mar 2026 Active
  • FDA 510(k) K170179 decided 18 Sep 2017 Active
  • FDA GUDID UDI-DI 07290117770030 listed 10 Aug 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170179
  2. Listed FDA GUDID 07290117770030
  3. Registered EUDAMED 729011777LSUW

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  • Withdrawn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
Dermatological diode laser system
Model / reference
GA-1140000Be EUDAMED
LightSheer® Quattro™ GUDID
Primary DI / UDI-DI
07290117770030
Basic UDI-DI
729011777LSUW
510(k) Number
FDA product code
GEX
EMDN code
Z12011016 Diode surgical laser
GMDN term
Dermatological diode 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
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
GA-1140000Be
GUDID
LightSheer® Quattro™
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 DIODE SURGICAL LASER.

Other devices from Lumenis Be Ltd

See all devices from Lumenis Be Ltd →

Properties

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