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AvalancheLase M071-2F/XP

by FOTONA d.o.o.

Ref M071-2F/XP

AvalancheLase M071-2F/XP is a device classified as Class IIb in the EU and Class II in the US made by FOTONA d.o.o., registered in EUDAMED on 15 Oct 2025 (Basic UDI-DI 3830054230007SD), cleared under FDA 510(k) K223540 on 19 Jan 2023 and listed in FDA GUDID since 20 Sep 2024 (UDI-DI 03830054230385), 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) K223540

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 Number3830054230007SD Basic UDI-DI 03830054230385UDI-DIDate15 Oct 2025RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number03830054230385 UDI-DI Date20 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223540 Date19 Jan 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3830054230007SD registered 15 Oct 2025 Active
  • FDA 510(k) K223540 decided 19 Jan 2023 Active
  • FDA GUDID UDI-DI 03830054230385 listed 20 Sep 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K223540
  2. Listed FDA GUDID 03830054230385
  3. Registered EUDAMED 3830054230007SD

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  • Withdrawn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
AvalancheLase
Generic name
Dermatological solid-state laser system
Model / reference
M071-2F/XP
Primary DI / UDI-DI
03830054230385
Basic UDI-DI
3830054230007SD
510(k) Number
FDA product code
GEX
EMDN code
Z12011019 Multi–platform laser
GMDN term
Dermatological 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: Dermatological 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.

See all devices from FOTONA d.o.o. →

Properties

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