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LightWalker Max M021-5AF/1 Max

by FOTONA d.o.o.

Part of a family of 10 devices: see the family page

Ref M021-5AF/1 Max

LightWalker Max M021-5AF/1 Max is a device classified as Class IIb in the EU and Class II in the US made by FOTONA d.o.o., cleared under FDA 510(k) K242202 on 23 Aug 2024, registered in EUDAMED on 13 Jun 2022 (Basic UDI-DI 3830054230004S7) and listed in FDA GUDID since 11 Jul 2025 (UDI-DI 03830054238176), 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) K242202

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03830054238176 UDI-DI Date11 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK242202 Date23 Aug 2024DecidedStatusActive
European UnionCE/MDR EUDAMED Number3830054230004S7 Basic UDI-DI 03830054238176UDI-DIDate13 Jun 2022RegisteredStatusActive EUDAMED: not on the EU market

Official records

Across registries

3 registries list this device

  • FDA 510(k) K242202 decided 23 Aug 2024 Active
  • EUDAMED Basic UDI-DI 3830054230004S7 registered 13 Jun 2022 Active
  • FDA GUDID UDI-DI 03830054238176 listed 11 Jul 2025 Listed

Timeline

3 dated events

  1. Registered EUDAMED 3830054230004S7
  2. Cleared FDA 510(k) K242202
  3. Listed FDA GUDID 03830054238176

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  • Withdrawn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
LightWalker Max
Generic name
General/multiple surgical solid-state laser system
Device name
LightWalker/TimeWalker
Model / reference
M021-5AF/1 Max
Primary DI / UDI-DI
03830054238176
Basic UDI-DI
3830054230004S7
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
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: General/multiple surgical solid-state laser systemDermatological solid-state laser systemDental solid-state laser systemMulti-modality skin surface treatment system generator

Similar devices in this category

Other devices filed under MULTI–PLATFORM LASER.

Other devices from FOTONA d.o.o.

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Properties

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