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Lumix 250
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref LUMIX250R3Model LUMIX 250Model LUMIX C.P.S.
Identity
- Trade Name
- LUMIX 250 EUDAMEDFDA UDI
- Generic Name
- Skin laser scanner FDA UDI
- Device Name
- LASER THERAPY UNIT LUMIX 250 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 5W FDA UDI
- Model / Reference
- LUMIX 250 EUDAMEDFDA UDILUMIX250R3 EUDAMEDLUMIX C.P.S. EUDAMED
- Description
- LASER THERAPY UNIT LUMIX 250 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 5W FDA UDI
Identifiers
- Catalog Number
- LUMIX250R3 FDA UDI
- Primary DI / UDI-DI
- 08057949171850 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057949171850 EUDAMED805794917001LAST3U EUDAMED
- Direct Marketing DI
- 08057949171850 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 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 — 20 Millimeter FDA UDILumen/Inner Diameter — 910 Nanometer FDA UDILumen/Inner Diameter — 650 Nanometer FDA UDI
Lumix 250 by Fisioline Srl — Class IIb — 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-08057949171850 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08057949171850 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Fisioline Srl
- EUDAMED SRN
- IT-MF-000027924
Sources (3)
- EUDAMED e65adab4-4f6f-40c2-93c8-5c7a54172442 61 fields · synced Jul 12, 2026
- EUDAMED 5915c63d-d30d-49ed-adee-03ff019bc464 61 fields · synced May 19, 2026
- FDA UDI 20e62a3d-fa06-4e61-a788-c7a83b0eaab7 38 fields · synced May 30, 2026