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V10 Console VRF2000

by Viora Ltd

Ref VRF2000Model V10

V10 Console VRF2000 is a device classified as Class IIb in the EU and Class I in the US made by Viora Ltd, registered in EUDAMED on 21 Jun 2026 (Basic UDI-DI B-07290016746020), cleared under FDA 510(k) K150035 on 1 May 2015 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07290016746020), 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) K150035

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-07290016746020 Basic UDI-DI 07290016746020UDI-DIDate21 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016746020 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK150035 Date1 May 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290016746020 registered 21 Jun 2026 Active
  • FDA 510(k) K150035 decided 1 May 2015 Active
  • FDA GUDID UDI-DI 07290016746020 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150035
  2. Listed FDA GUDID 07290016746020
  3. Registered EUDAMED B-07290016746020

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  • Withdrawn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

Trade name
V10 EUDAMED
V10 Console GUDID
Generic name
Radio-frequency skin surface treatment system
Model / Ref / Catalog
VRF2000, V10
Primary DI / UDI-DI
07290016746020
Basic UDI-DI
B-07290016746020
510(k) Number
FDA product code
ISA, PBX
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Radio-frequency skin surface treatment system
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
890.5660, 878.4400
System or procedure pack
System which is a device in itself
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 I

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Radio-frequency skin surface treatment system

Cleared under the same submission (K150035)

and 2 more cleared under K150035

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Viora Ltd

See all devices from Viora Ltd →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)