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Lumix 2
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref L2PC01Model LUMIX 2Model LUMIX C.P.S.
Identity
- Trade Name
- LUMIX 2 EUDAMEDFDA UDI
- Generic Name
- Skin laser scanner FDA UDI
- Device Name
- LASER THERAPY UNIT LUMIX 2 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) FDA UDI
- Model / Reference
- LUMIX 2 EUDAMEDFDA UDIL2PC01 EUDAMEDLUMIX C.P.S. EUDAMED
- Description
- LASER THERAPY UNIT LUMIX 2 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) FDA UDI
Identifiers
- Catalog Number
- L2PC01 FDA UDI
- Primary DI / UDI-DI
- 08057949170013 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057949170013 EUDAMED805794917001LAST3U EUDAMED
- Direct Marketing DI
- 08057949170013 EUDAMED
- 510(k) Number
- K042256 FDA UDI
- FDA Product Code
- ILY FDA UDI
- EMDN Code
- Z120615 THERAPEUTIC LASERS EUDAMED
- GMDN Term
- Skin laser scanner FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 910 Nanometer FDA UDILumen/Inner Diameter — 650 Nanometer FDA UDILumen/Inner Diameter — 10 Millimeter FDA UDI
Lumix 2 by Fisioline Srl — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08057949170013 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08057949170013 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Fisioline Srl
- EUDAMED SRN
- IT-MF-000027924
Sources (3)
- EUDAMED 0496cc4b-d0c1-45dc-96f2-d6e431661613 61 fields · synced Jul 9, 2026
- EUDAMED c0e570a1-247d-44b4-b70f-0f55ccb02a1b 61 fields · synced May 18, 2026
- FDA UDI 6f33b5c4-cc1b-4cd0-9b26-8bf0eccd4aef 38 fields · synced May 30, 2026