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HR650 applicator AS120031

by Venus Concept Inc.

Ref AS120031

HR650 applicator AS120031 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-00810060830789), cleared under FDA 510(k) K153717 on 21 Mar 2016 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00810060830789), 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-00810060830789 Basic UDI-DI 00810060830789UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810060830789 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-00810060830789 registered 6 Nov 2026 Active
  • FDA 510(k) K153717 decided 21 Mar 2016 Active
  • FDA GUDID UDI-DI 00810060830789 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153717
  2. Listed FDA GUDID 00810060830789
  3. Registered EUDAMED B-00810060830789

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  • Withdrawn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
HR650 applicator
Generic name
Light-energy skin surface treatment system applicator
Model / reference
AS120031
Primary DI / UDI-DI
00810060830789 EUDAMED
07290016540413 GUDID
Basic UDI-DI
B-00810060830789
FDA product code
ONF
EMDN code
X0502 High intensity electromagnetic radiation emitting equipment without an intended medical purpose intended for use on the human body, for skin resurfacing, tattoo or hair removal or other skin treatment – intense pulsed light
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
00810060830789
GUDID
07290016540413
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00810060830789; FDA GUDID lists 07290016540413), 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 HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT.

Other devices from Venus Concept Inc.

See all devices from Venus Concept Inc. →

Properties

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