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Lumix Cw
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref LCW1402Model LUMIX C.P.S.Model LUMIX CW
Identity
- Trade Name
- LUMIX CW EUDAMEDFDA UDI
- Generic Name
- Skin laser scanner FDA UDI
- Device Name
- LASER THERAPY UNIT LUMIX CW with 3 WAVELENGTH (650nm+810nm+1064nm) FDA UDI
- Model / Reference
- LUMIX C.P.S. EUDAMEDLCW1402 EUDAMEDFDA UDILUMIX CW EUDAMED
- Description
- LASER THERAPY UNIT LUMIX CW with 3 WAVELENGTH (650nm+810nm+1064nm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057949170280 EUDAMEDFDA UDI
- Basic UDI-DI
- 805794917001LAST3U EUDAMEDB-08057949170280 EUDAMED
- Direct Marketing DI
- 08057949170280 EUDAMED
- 510(k) Number
- K052814 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 — 10 Millimeter FDA UDILumen/Inner Diameter — 650 Nanometer FDA UDILumen/Inner Diameter — 810 Nanometer FDA UDILumen/Inner Diameter — 1064 Nanometer FDA UDI
Lumix Cw by Fisioline Srl — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 805794917001LAST3U | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 805794917001LAST3U | 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 d7507d73-34cc-448a-ba57-656a496302dc 61 fields · synced Sep 17, 2026
- EUDAMED 793e1bba-c1de-41fc-8f91-1ae046f2d0e7 61 fields · synced May 19, 2026
- FDA UDI ebe1fe16-4c18-49d2-9887-f1608b9cd671 37 fields · synced May 29, 2026