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HR-Max FS80022

by Formatk Systems Ltd

Ref FS80022

HR-Max FS80022 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 21 Aug 2026 (Basic UDI-DI 7290016681AL000301UM), cleared under FDA 510(k) K162781 on 9 Nov 2016 and listed in FDA GUDID since 25 Jun 2021 (UDI-DI 07290016681444), 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) K162781

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7290016681AL000301UM Basic UDI-DI 07290016681444UDI-DIDate21 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016681444 UDI-DI Date25 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK162781 Date9 Nov 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7290016681AL000301UM registered 21 Aug 2026 Active
  • FDA 510(k) K162781 decided 9 Nov 2016 Active
  • FDA GUDID UDI-DI 07290016681444 listed 25 Jun 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K162781
  2. Listed FDA GUDID 07290016681444
  3. Registered EUDAMED 7290016681AL000301UM

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  • Withdrawn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
HR Max EUDAMED
HR-Max GUDID
Generic name
Dermatological laser beam guiding handpiece
Model / Ref / Catalog
FS80022
Primary DI / UDI-DI
07290016681444
Basic UDI-DI
7290016681AL000301UM
510(k) Number
FDA product code
GEX
EMDN code
Z12040201, Z12040203
GMDN term
Dermatological laser beam guiding handpiece
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: Dermatological laser beam guiding handpiece

Cleared under the same submission (K162781)

Similar devices in this category

Other devices filed under PHOTOEPILATION EQUIPMENT.

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Properties

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