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Diode Laser Therapy System

by Beijing ADSS Development Co., Ltd 2 variants

Ref FG2000-EModel FG2000-D+; FG2000-D+Pro; FG2000-E

Diode Laser Therapy System (FG2000-E) is a device classified as Class IIa in the EU and Class II in the US made by Beijing ADSS Development Co., Ltd., registered in EUDAMED on 24 Jun 2025 (Basic UDI-DI 697045327FG20005Q), cleared under FDA 510(k) K231896 on 20 Feb 2024 and listed in FDA GUDID since 30 Oct 2025 (UDI-DI 06970453270838), 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) K231896↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06970453270838 UDI-DI Date30 Oct 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697045327FG20005Q Basic UDI-DI 06970453270838UDI-DIDate24 Jun 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK231896 Date20 Feb 2024IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697045327FG20005Q registered 24 Jun 2025 Active
  • FDA 510(k) K231896 decided 20 Feb 2024 Active
  • FDA GUDID UDI-DI 06970453270838 listed 30 Oct 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231896
  2. Registered EUDAMED 697045327FG20005Q
  3. Listed FDA GUDID 06970453270838

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
Diode Laser Therapy System EUDAMED
Diode Laser Therapy Machine GUDID
Generic name
Dermatological diode laser system
Model / reference
FG2000-D+, FG2000-D+Pro, FG2000-E
Primary DI / UDI-DI
06970453270838 EUDAMED
06970453270210 GUDID
Basic UDI-DI
697045327FG20005Q
Direct marketing DI
06970453270838
510(k) Number
FDA product code
GEX
EMDN code
Z12011016 Diode surgical laser
GMDN term
Dermatological diode laser system
Device class
Class IIa 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
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06970453270838
GUDID
06970453270210
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06970453270838; FDA GUDID lists 06970453270210), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CN-MF-000013103
Authorised representative
Prolinx GmbH DE-AR-000005129

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Properties

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