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Lumix 2

by Fisioline SRL

Lumix 2 (L2PC02) is a Class II device made by Fisioline SRL, cleared under FDA 510(k) K042256 on 17 Nov 2004, registered in EUDAMED and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 08057949170020), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K042256

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08057949170020 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK042256 Date17 Nov 2004DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K042256 decided 17 Nov 2004 Active
  • EUDAMED Active· +1 more in the status table
  • FDA GUDID UDI-DI 08057949170020 listed 20 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K042256
  2. Listed FDA GUDID 08057949170020

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  • Withdrawn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
Skin laser scanner
Model / Ref / Catalog
LUMIX 2, L2PC02
Primary DI / UDI-DI
08057949170020
510(k) Number
FDA product code
ILY
GMDN term
Skin laser scanner
Device class
Class II
Regulation number
890.5500
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 910 Nanometer
Lumen/Inner Diameter — 650 Nanometer
Lumen/Inner Diameter — 10 Millimeter

Related devices

Category: Skin laser scanner

Cleared under the same submission (K042256)

Similar devices

Other devices filed under FDA product code ILY (Lamp, Infrared, Therapeutic Heating).

Other devices from Fisioline SRL

See all devices from Fisioline SRL →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)