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AcuPulse™ Upgrade Kit 40 to 40AES-R

by Lumenis Be LTD

Ref UG-0000370Be

AcuPulse Upgrade Kit 40 to 40AES-R (UG-0000370Be) is a medical device (EU MDR Class IIb; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument; EMDN category laser surgery instruments - hardware accessories) made by Lumenis Be Ltd, registered in EUDAMED on 9 Apr 2026 (Basic UDI-DI 729011777APUGEG), cleared under FDA 510(k) K212703 on 19 Oct 2021 and listed in FDA GUDID since 4 Dec 2023 (UDI-DI 07290117771532), 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) K212703

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 Number729011777APUGEG Basic UDI-DI 07290117771532UDI-DIDate9 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290117771532 UDI-DI Date4 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212703 Date19 Oct 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729011777APUGEG registered 9 Apr 2026 Active
  • FDA 510(k) K212703 decided 19 Oct 2021 Active
  • FDA GUDID UDI-DI 07290117771532 listed 4 Dec 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212703
  2. Listed FDA GUDID 07290117771532
  3. Registered EUDAMED 729011777APUGEG

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  • Withdrawn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
General/multiple surgical carbon dioxide laser system
Model / reference
UG-0000370Be
Primary DI / UDI-DI
07290117771532
Basic UDI-DI
729011777APUGEG
510(k) Number
FDA product code
GEX
EMDN code
Z12011080 Laser surgery instruments - hardware accessories
GMDN term
General/multiple surgical carbon dioxide laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
EU market of registration
Germany
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 LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

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)