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SP Dynamis

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

Ref M021-4AF/3

SP Dynamis (M021-4AF/3) 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 15 Dec 2023 (Basic UDI-DI B-03830054230101), cleared under FDA 510(k) K213267 on 8 Sep 2022 (2 earlier submissions) and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 03830054230101), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213267

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-03830054230101 Basic UDI-DI 03830054230101UDI-DIDate15 Dec 2023RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-03830054230101 Basic UDI-DI 03830054230101UDI-DIDate15 Dec 2023RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213267 Date8 Sep 2022DecidedStatusActive
United StatesGUDID listing GUDID Number03830054230101 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03830054230101 registered 15 Dec 2023 Active· +1 more in the status table
  • FDA 510(k) K213267 decided 8 Sep 2022 Active· +2 more in the status table
  • FDA GUDID UDI-DI 03830054230101 listed 19 Sep 2016 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K143723
  2. Listed FDA GUDID 03830054230101
  3. Cleared FDA 510(k) K182088
  4. Cleared FDA 510(k) K213267
  5. Registered EUDAMED B-03830054230101

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD 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
M021-4AF/3
Primary DI / UDI-DI
03830054230101
Basic UDI-DI
B-03830054230101, 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
Legacy device (under a directive)
Standard device
EU market of registration
Czechia
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)