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Lumenis LaserLink Z (Kit, Zeiss SL130 w/manip. / Spectra & Varia)

by Lumenis Be Inc

Ref 0642-715-01BE , 0642-716-01BE

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081009633PCABF Basic UDI-DI 00810096330352UDI-DIDate12 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810096330352 UDI-DI Date2 Apr 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

1 recall · FDA

    • Terminated Z-2191-2013 FDA Class II initiated 19 Aug 2013

    Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.

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  • Withdrawn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
Lumenis LaserLink Z (Kit, Zeiss SL130 w/manip. / Spectra & Varia) EUDAMED
LaserLink Z GUDID
Generic Name
Laser adaptor
Model / Reference
0642-715-01BE, 0642-716-01BE
Primary DI / UDI-DI
00810096330352
Basic UDI-DI
081009633PCABF
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011099 Laser surgery instruments - other
GMDN Term
Laser adaptor
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4810
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000016037
Authorised representative
Lumenis (Germany) GmbH DE-AR-000007699

Other devices from Lumenis Be, Inc.

See all devices from Lumenis Be, Inc. →

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