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ACDUAL applicator AS120058

by Venus Concept Inc.

Ref AS120058

ACDUAL applicator AS120058 is a device classified as Class IIb in the EU and Class II in the US made by Venus Concept Inc., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-00810060830734), cleared under FDA 510(k) K153717 on 21 Mar 2016 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00810060830734), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153717

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/MDD EUDAMED NumberB-00810060830734 Basic UDI-DI 00810060830734UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810060830734 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153717 Date21 Mar 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00810060830734 registered 6 Nov 2026 Active
  • FDA 510(k) K153717 decided 21 Mar 2016 Active
  • FDA GUDID UDI-DI 00810060830734 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153717
  2. Listed FDA GUDID 00810060830734
  3. Registered EUDAMED B-00810060830734

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  • Withdrawn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
ACDUAL applicator
Generic name
Light-energy skin surface treatment system applicator
Model / reference
AS120058
Primary DI / UDI-DI
00810060830734 EUDAMED
07290016540451 GUDID
Basic UDI-DI
B-00810060830734
FDA product code
ONF
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Light-energy skin surface treatment system applicator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00810060830734
GUDID
07290016540451
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00810060830734; FDA GUDID lists 07290016540451), so their flags are not compared. 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: Light-energy skin surface treatment system applicator

Cleared under the same submission (K153717)

and 8 more cleared under K153717

Similar devices in this category

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

Other devices from Venus Concept Inc.

See all devices from Venus Concept Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (21, all answered No)