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Lumix Ultra
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref LULTRA35HPModel LUMIX ULTRAModel LUMIX C.P.S.
Identity
- Trade Name
- LUMIX ULTRA EUDAMEDLUMIX ULTRA/PLUS FDA UDI
- Generic Name
- Skin laser scanner FDA UDI
- Device Name
- LASER THERAPY LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm) FDA UDI
- Model / Reference
- LUMIX ULTRA EUDAMEDLULTRA35HP EUDAMEDLUMIX C.P.S. EUDAMEDLUMIX ULTRA 1 FDA UDI
- Description
- LASER THERAPY LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm) FDA UDI
Identifiers
- Catalog Number
- LULTRA35HP FDA UDI
- Primary DI / UDI-DI
- 08057949171584 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057949171584 EUDAMED805794917001LAST3U EUDAMED
- Direct Marketing DI
- 08057949171584 EUDAMED
- 510(k) Number
- K161198 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 — 650 Nanometer FDA UDILumen/Inner Diameter — 910 Nanometer FDA UDILumen/Inner Diameter — 1064 Nanometer FDA UDI
Lumix Ultra 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-08057949171584 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08057949171584 | 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 b7f0191d-f2ff-4500-983a-7e85738c678c 61 fields · synced Jun 19, 2026
- EUDAMED 055c2041-796a-4efd-bf0f-dcabe56a5fa0 61 fields · synced May 17, 2026
- FDA UDI d8eb8039-d676-49b3-8f29-502cdf1823c0 38 fields · synced May 30, 2026