Skip to content

Forma Light FS60000

by Formatk Systems Ltd

Ref FS60000

Forma Light FS60000 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 7290016681SI0001005F), cleared under FDA 510(k) K160195 on 15 Apr 2016 and listed in FDA GUDID since 18 Aug 2017 (UDI-DI 07290016681017), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160195

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7290016681SI0001005F Basic UDI-DI 07290016681017UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016681017 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 7290016681SI0001005F registered 20 Aug 2026 Active
  • FDA 510(k) K160195 decided 15 Apr 2016 Active
  • FDA GUDID UDI-DI 07290016681017 listed 18 Aug 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160195
  2. Listed FDA GUDID 07290016681017
  3. Registered EUDAMED 7290016681SI0001005F

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  • Withdrawn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
Forma Light
Generic name
Cosmetic red-light phototherapy system, professional
Model / Ref / Catalog
FS60000
Description
System supporting IPL (Intense Pulsed Light) applicators for various treatments such as Hair Removal, Acne, Pigmented Lesions
Primary DI / UDI-DI
07290016681017
Basic UDI-DI
7290016681SI0001005F
510(k) Number
FDA product code
ONF
EMDN code
Z12040201, Z12040203
GMDN term
Cosmetic red-light phototherapy system, professional
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: Cosmetic red-light phototherapy system, professional

Cleared under the same submission (K160195)

and 8 more cleared under K160195

Similar devices in this category

Other devices filed under PHOTOEPILATION EQUIPMENT.

Other devices from Formatk Systems Ltd

  • R-Sonic

    Class IIa

  • Magma Spark Cart FS80001

    Class I

  • B-Hr FS10006

    Class II

  • Magma FS70000

    Class II

See all devices from Formatk Systems Ltd →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)