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V-VR Handpiece VTL48010

by Viora Ltd

Ref VTL48010Model V-VR Handpiece

V-VR Handpiece VTL48010 is a device classified as Class IIb in the EU and Class II in the US made by Viora Ltd, registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI B-07290016746471), cleared under FDA 510(k) K202247 on 9 Dec 2020 and listed in FDA GUDID since 3 Jun 2025 (UDI-DI 07290016746471), 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) K202247

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-07290016746471 Basic UDI-DI 07290016746471UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016746471 UDI-DI Date3 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202247 Date9 Dec 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290016746471 registered 24 Jun 2026 Active
  • FDA 510(k) K202247 decided 9 Dec 2020 Active
  • FDA GUDID UDI-DI 07290016746471 listed 3 Jun 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K202247
  2. Listed FDA GUDID 07290016746471
  3. Registered EUDAMED B-07290016746471

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  • Withdrawn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
V-VR Handpiece
Generic name
Multi-modality skin surface treatment system
Model / Ref / Catalog
VTL48010, V-VR Handpiece
Primary DI / UDI-DI
07290016746471
Basic UDI-DI
B-07290016746471
510(k) Number
FDA product code
PBX, ISA
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Multi-modality skin surface treatment system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400, 890.5660
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 07290016746471: EUDAMED states Yes, FDA GUDID states No.

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: Multi-modality skin surface treatment system

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

  • Supplied sterile YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)