Identity
- Trade Name
- LUMIX CPS EUDAMEDLUMIX C.P.S. FDA UDI
- Generic Name
- Skin laser scanner FDA UDI
- Device Name
- LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) FDA UDI
- Model / Reference
- LUMIX CPS EUDAMEDLCPS5 EUDAMEDLUMIX C.P.S.5 FDA UDI
- Description
- LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) FDA UDI
Identifiers
- Catalog Number
- LCPS5 FDA UDI
- Primary DI / UDI-DI
- 08057949170068 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057949170068 EUDAMED
- 510(k) Number
- K160947 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — 10 Millimeter FDA UDILumen/Inner Diameter — 1064 Nanometer FDA UDILumen/Inner Diameter — 910 Nanometer FDA UDILumen/Inner Diameter — 810 Nanometer FDA UDILumen/Inner Diameter — 650 Nanometer FDA UDI
Lumix Cps by Fisioline Srl — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08057949170068 | 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 (2)
- EUDAMED 36e812b2-fc1b-44d1-8e68-ccc004d5bef3 61 fields · synced Jun 19, 2026
- FDA UDI ad32050b-3e90-4c08-a5f5-c89a19c0f8c6 38 fields · synced May 29, 2026