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B-Hr FS10006

by Formatk Systems Ltd

Ref FS10006

B-Hr FS10006 is a device classified as Class IIb in the EU and Class II in the US made by Formatk Systems Ltd, registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI 7290016681AI000500TA), cleared under FDA 510(k) K160195 on 15 Apr 2016 (1 earlier submission) and listed in FDA GUDID since 18 Aug 2017 (UDI-DI 07290016681246), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 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) K160195

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7290016681AI000500TA Basic UDI-DI 07290016681246UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016681246 UDI-DI Date18 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160195 Date15 Apr 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7290016681AI000500TA registered 20 Aug 2026 Active
  • FDA 510(k) K160195 decided 15 Apr 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07290016681246 listed 18 Aug 2017 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K153566
  2. Cleared FDA 510(k) K160195
  3. Listed FDA GUDID 07290016681246
  4. Registered EUDAMED 7290016681AI000500TA

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
B-Hr
Generic name
Light-energy skin surface treatment system applicator
Model / Ref / Catalog
FS10006
Primary DI / UDI-DI
07290016681246
Basic UDI-DI
7290016681AI000500TA
510(k) Number
FDA product code
ONF
EMDN code
Z12040201, Z12040203
GMDN term
Light-energy skin surface treatment system applicator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
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: Light-energy skin surface treatment system applicator

Cleared under the same submission (K153566)

and 8 more cleared under K153566

Cleared under the same submission (K160195)

and 8 more cleared under K160195

Similar devices in this category

Other devices filed under PHOTOEPILATION EQUIPMENT.

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See all devices from Formatk Systems Ltd →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)