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DeepFX™ Air Disposable Tips

by Lumenis Be LTD

Ref KT-00055555Be

DeepFX Air Disposable Tips (KT-00055555Be) is a laser beam-guide spacer (EU MDR Class I; 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 729011777DPFXTPSSP), cleared under FDA 510(k) K233301 on 1 Dec 2023 (1 earlier submission) and listed in FDA GUDID since 4 Dec 2023 (UDI-DI 17290117771836), 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, self-declared

Class I: no certifier involved

510(k) K233301

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011777DPFXTPSSP Basic UDI-DI 17290117771836UDI-DIDate25 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number17290117771836 UDI-DI Date4 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK233301 Date1 Dec 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729011777DPFXTPSSP registered 25 Mar 2026 Active
  • FDA 510(k) K233301 decided 1 Dec 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 17290117771836 listed 4 Dec 2023 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

4 dated events

  1. Cleared FDA 510(k) K212703
  2. Cleared FDA 510(k) K233301
  3. Listed FDA GUDID 17290117771836
  4. Registered EUDAMED 729011777DPFXTPSSP

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  • Withdrawn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
Laser beam-guide spacer
Model / reference
KT-00055555Be
Primary DI / UDI-DI
17290117771836
Basic UDI-DI
729011777DPFXTPSSP
510(k) Number
FDA product code
GEX
EMDN code
Z12011080 Laser surgery instruments - hardware accessories
GMDN term
Laser beam-guide spacer
Device class
Class I 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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)