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LB1 applicator AS100006

by Venus Concept Inc.

Ref AS100006

LB1 applicator AS100006 is a radio-frequency skin contouring system applicator (EU MDD Class IIb; FDA Class II) made by Venus Concept Inc., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-00810060830857), cleared under FDA 510(k) K191528 on 6 Sep 2019 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00810060830857), 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) K191528

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00810060830857 Basic UDI-DI 00810060830857UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191528 Date6 Sep 2019DecidedStatusActive
United StatesGUDID listing GUDID Number00810060830857 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00810060830857 registered 6 Nov 2026 Active
  • FDA 510(k) K191528 decided 6 Sep 2019 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00810060830857 listed 24 Sep 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K143554
  2. Listed FDA GUDID 00810060830857
  3. Cleared FDA 510(k) K191528
  4. Registered EUDAMED B-00810060830857

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  • Withdrawn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
LB1 applicator
Generic name
Radio-frequency skin contouring system applicator, bipolar
Model / reference
AS100006
Primary DI / UDI-DI
00810060830857 EUDAMED
07290016540024 GUDID
Basic UDI-DI
B-00810060830857
FDA product code
PBX, GEI
EMDN code
X0599 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
GMDN term
Radio-frequency skin contouring system applicator, bipolar
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
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
00810060830857
GUDID
07290016540024
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00810060830857; FDA GUDID lists 07290016540024), 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: Radio-frequency skin contouring system applicator, bipolar

Cleared under the same submission (K143554)

and 8 more cleared under K143554

Cleared under the same submission (K191528)

and 8 more cleared under K191528

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)