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VISULAS green

by Carl Zeiss Meditec AG 3 variants

Ref 2096-101Model VISULAS green

VISULAS green is a device classified as Class IIb in the EU and Class II in the US made by Carl Zeiss Meditec AG, registered in EUDAMED on 29 Jul 2026 (Basic UDI-DI B-04049471091434), cleared under FDA 510(k) K181682 on 6 Mar 2019 and listed in FDA GUDID since 2 May 2019 (UDI-DI 04049471091434), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 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) K181682

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/MDD EUDAMED NumberB-04049471091434 Basic UDI-DI 04049471091434UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049471091434 UDI-DI Date2 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181682 Date6 Mar 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04049471091434 registered 29 Jul 2026 Active
  • FDA 510(k) K181682 decided 6 Mar 2019 Active
  • FDA GUDID UDI-DI 04049471091434 listed 2 May 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181682
  2. Listed FDA GUDID 04049471091434
  3. Registered EUDAMED B-04049471091434

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
General/multiple surgical frequency-doubled solid-state laser system
Model / reference
VISULAS green, 2096-101
Primary DI / UDI-DI
04049471091434
Basic UDI-DI
B-04049471091434
Direct marketing DI
04049471091434
510(k) Number
FDA product code
HQF
EMDN code
Z12120202 Laser photocoagulators
GMDN term
General/multiple surgical frequency-doubled solid-state laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
886.4390
EU registration type
Legacy device (under a directive)
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.

Related devices

Category: General/multiple surgical frequency-doubled solid-state laser systemOphthalmic solid-state laser system

Cleared under the same submission (K181682)

Similar devices in this category

Other devices filed under LASER PHOTOCOAGULATORS.

Other devices from Carl Zeiss Meditec AG

See all devices from Carl Zeiss Meditec AG →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)