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iLux LF D10 1LFD10

by Mectronic Medicale SRL

Ref 10LFD10Model ILUX LF D10

iLux LF D10 1LFD10 is a device classified as Class IIb in the EU and Class II in the US made by Mectronic Medicale SRL, registered in EUDAMED on 13 May 2026 (Basic UDI-DI B-08051499971557) and listed in FDA GUDID since 18 Sep 2024 (UDI-DI 08051499971557), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08051499971557 Basic UDI-DI 08051499971557UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08051499971557 UDI-DI Date18 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08051499971557 registered 13 May 2026 Active
  • FDA GUDID UDI-DI 08051499971557 listed 18 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08051499971557
  2. Registered EUDAMED B-08051499971557

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
ILUX SMART (10W 810+980nm) EUDAMED
iLux LF D10 GUDID
Generic name
Musculoskeletal/physical therapy laser, professional
Model / reference
ILUX LF D10 EUDAMED
10LFD10 EUDAMED
1LFD10 GUDID
Primary DI / UDI-DI
08051499971557
Basic UDI-DI
B-08051499971557
FDA product code
ILY
EMDN code
Z120615 Therapeutic lasers
GMDN term
Musculoskeletal/physical therapy laser, professional
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
890.5500
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ILUX LF D10
10LFD10
GUDID
1LFD10
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: Musculoskeletal/physical therapy laser, professional

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Other devices filed under THERAPEUTIC LASERS.

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)