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Alpha FS90000

by Formatk Systems Ltd

Ref FS90000

Alpha FS90000 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 7290016681SIL00202GP), cleared under FDA 510(k) K183307 on 11 Dec 2018 and listed in FDA GUDID since 16 Dec 2018 (UDI-DI 07290016681062), 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) K183307

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 Number7290016681SIL00202GP Basic UDI-DI 07290016681062UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016681062 UDI-DI Date16 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK183307 Date11 Dec 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7290016681SIL00202GP registered 20 Aug 2026 Active
  • FDA 510(k) K183307 decided 11 Dec 2018 Active
  • FDA GUDID UDI-DI 07290016681062 listed 16 Dec 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183307
  2. Listed FDA GUDID 07290016681062
  3. Registered EUDAMED 7290016681SIL00202GP

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  • Withdrawn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
Alpha
Generic name
Multi-modality skin surface treatment system
Model / Ref / Catalog
FS90000
Primary DI / UDI-DI
07290016681062
Basic UDI-DI
7290016681SIL00202GP
510(k) Number
FDA product code
ONF, GEX
EMDN code
Z12040201, Z12040203
GMDN term
Multi-modality skin surface treatment system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
System or procedure pack
System which is a device in itself
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: Multi-modality skin surface treatment system

Cleared under the same submission (K183307)

and 5 more cleared under K183307

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
  • Manufacturing date
Other properties (22, all answered No)