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Opti-Tip™

by Lumenis Be LTD

Ref KT-00022901Be

Opti-Tip (KT-00022901Be) is an intense pulsed light dry eye therapy unit (EU MDR Class IIb; FDA Class II; FDA product code QIU, Intense Pulsed Light Device For Managing Dry Eye) made by Lumenis Be Ltd, registered in EUDAMED on 25 Mar 2026 (Basic UDI-DI 729011777OPTTPK6) and listed in FDA GUDID since 21 Mar 2023 (UDI-DI 07290117771747), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011777OPTTPK6 Basic UDI-DI 07290117771747UDI-DIDate25 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290117771747 UDI-DI Date21 Mar 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 729011777OPTTPK6 registered 25 Mar 2026 Active
  • FDA GUDID UDI-DI 07290117771747 listed 21 Mar 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290117771747
  2. Registered EUDAMED 729011777OPTTPK6

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  • Withdrawn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

Generic name
Intense pulsed light dry eye therapy unit
Model / reference
KT-00022901Be
Primary DI / UDI-DI
07290117771747
Basic UDI-DI
729011777OPTTPK6
FDA product code
QIU
EMDN code
Z12011019 Multi–platform laser
GMDN term
Intense pulsed light dry eye therapy unit
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
886.5201
EU registration type
Standard device
EU market of registration
Bulgaria
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

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Properties

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