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XS Dynamis

by FOTONA, proizvodnja optoelektronskih naprav d.o.o.

Ref M002-2A

XS Dynamis (M002-2A) is a general/multiple surgical solid-state laser system (EU MDR Class IIb; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by FOTONA, proizvodnja optoelektronskih naprav d.o.o., registered in EUDAMED on 16 Oct 2025 (Basic UDI-DI 3830054230005S9), cleared under FDA 510(k) K213267 on 8 Sep 2022 (2 earlier submissions) and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 03830054230125), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213267

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3830054230005S9 Basic UDI-DI 03830054230125UDI-DIDate16 Oct 2025RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213267 Date8 Sep 2022DecidedStatusActive
United StatesGUDID listing GUDID Number03830054230125 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3830054230005S9 registered 16 Oct 2025 Active
  • FDA 510(k) K213267 decided 8 Sep 2022 Active· +2 more in the status table
  • FDA GUDID UDI-DI 03830054230125 listed 19 Sep 2016 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K143723
  2. Listed FDA GUDID 03830054230125
  3. Cleared FDA 510(k) K182088
  4. Cleared FDA 510(k) K213267
  5. Registered EUDAMED 3830054230005S9

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  • Withdrawn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

Generic name
General/multiple surgical solid-state laser system
Device name
Dynamis/Spectro
Model / reference
M002-2A
Primary DI / UDI-DI
03830054230125
Basic UDI-DI
3830054230005S9
510(k) Number
FDA product code
GEX
EMDN code
Z12011019 Multi–platform laser
GMDN term
General/multiple surgical solid-state laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
EU market of registration
Italy
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.

Manufacturer details

EUDAMED SRN
SI-MF-000000126

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Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)