Identity
- Trade Name
- LUMIX Q EUDAMEDFDA UDI
- Generic Name
- Skin laser scanner FDA UDI
- Device Name
- LASER THERAPY UNIT LUMIX Q with 2 WAVELENGTH (650nm+1064nm) FDA UDI
- Model / Reference
- LUMIX Q EUDAMEDLUMIXQ01 EUDAMEDLUMIX C.P.S. 3 FDA UDI
- Description
- LASER THERAPY UNIT LUMIX Q with 2 WAVELENGTH (650nm+1064nm) FDA UDI
Identifiers
- Catalog Number
- LUMIXQ01 FDA UDI
- Primary DI / UDI-DI
- 08057949171645 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057949171645 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
Yes
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 — 650 Nanometer FDA UDILumen/Inner Diameter — 1064 Nanometer FDA UDI
Lumix Q 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-08057949171645 | 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 b64deb74-36be-407b-8fc5-a00603b74ed7 61 fields · synced Jul 9, 2026
- FDA UDI 5ca59772-d1eb-483e-ba2b-8aa7c66d2399 38 fields · synced May 30, 2026