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neoV neoV980

by G.N.S Neolaser Ltd

Ref BG98000Model neoV980

neoV neoV980 (BG98000) is a device classified as Class IIb in the EU and Class II in the US made by G.N.S Neolaser Ltd, registered in EUDAMED on 25 May 2026 (Basic UDI-DI 729001662929C6), cleared under FDA 510(k) K133006 on 17 Apr 2014 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 07290016629002), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K133006

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729001662929C6 Basic UDI-DI 07290016629002UDI-DIDate25 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016629002 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK133006 Date17 Apr 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729001662929C6 registered 25 May 2026 Active
  • FDA 510(k) K133006 decided 17 Apr 2014 Active
  • FDA GUDID UDI-DI 07290016629002 listed 1 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K133006
  2. Listed FDA GUDID 07290016629002
  3. Registered EUDAMED 729001662929C6

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  • Withdrawn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

Trade name
neoV980 EUDAMED
neoV GUDID
Generic name
General/multiple surgical diode laser system
Device name
neov980/Diode laser
Model / Ref / Catalog
neoV980, BG98000
Primary DI / UDI-DI
07290016629002
Basic UDI-DI
729001662929C6
Direct marketing DI
07290016629002
510(k) Number
FDA product code
GEX
EMDN code
Z12011016 Diode surgical laser
GMDN term
General/multiple surgical diode 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.

Related devices

Category: General/multiple surgical diode laser system

Cleared under the same submission (K133006)

and 8 more cleared under K133006

Similar devices in this category

Other devices filed under DIODE SURGICAL LASER.

Other devices from G.N.S Neolaser Ltd

See all devices from G.N.S Neolaser Ltd →

Properties

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