Skip to content

V-St Hp V-ST2001

by Viora Ltd

Ref V-ST2001Model V-ST Handpiece

V-St Hp V-ST2001 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-07290016746280), cleared under FDA 510(k) K152611 on 19 Feb 2016 (3 earlier submissions) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07290016746280), 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) K152611

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290016746280 Basic UDI-DI 07290016746280UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016746280 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK152611 Date19 Feb 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290016746280 registered 24 Jun 2026 Active
  • FDA 510(k) K152611 decided 19 Feb 2016 Active· +3 more in the status table
  • FDA GUDID UDI-DI 07290016746280 listed 23 Sep 2016 Listed

Timeline

6 dated events

  1. Cleared FDA 510(k) K133837
  2. Cleared FDA 510(k) K142093
  3. Cleared FDA 510(k) K150035
  4. Cleared FDA 510(k) K152611
  5. Listed FDA GUDID 07290016746280
  6. Registered EUDAMED B-07290016746280

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  • Withdrawn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-ST Handpiece EUDAMED
V-St Hp GUDID
Generic name
Radio-frequency skin contouring system applicator, bipolar
Model / Ref / Catalog
V-ST2001, V-ST Handpiece
Primary DI / UDI-DI
07290016746280
Basic UDI-DI
B-07290016746280
510(k) Number
FDA product code
PBX
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Radio-frequency skin contouring system applicator, bipolar
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
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 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: Radio-frequency skin contouring system applicator, bipolar

Cleared under the same submission (K133837)

and 8 more cleared under K133837

Cleared under the same submission (K142093)

and 8 more cleared under K142093

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)