Identity
- Trade Name
- LUMIX 2 FDA UDI
- Generic Name
- Skin laser scanner FDA UDI
- Device Name
- LASER THERAPY UNIT LUMIX 2 with 2 WAVELENGTH FDA UDI
- Model / Reference
- LUMIX 2 FDA UDI
- Description
- LASER THERAPY UNIT LUMIX 2 with 2 WAVELENGTH FDA UDI
Identifiers
- Catalog Number
- L2PC02 FDA UDI
- Primary DI / UDI-DI
- 08057949170020 FDA UDI
- 510(k) Number
- K042256 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Skin laser scanner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 — 910 Nanometer FDA UDILumen/Inner Diameter — 650 Nanometer FDA UDILumen/Inner Diameter — 10 Millimeter FDA UDI
Category: Skin laser scanner
Lumix 2 by Fisioline Srl — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Skin laser scanner.
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- UltraScan CPG — Lumenis Be, Inc. · Class II
- OptiScan — Quanta System Spa · Class II
- DeepFX ™ Microscanner — Lumenis Be, Inc. · Class II
Cleared under the same submission
K042256 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fisioline Srl
Sources (2)
- FDA UDI 9a0f7d69-497c-4f8a-acdd-68c845883b21 38 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026