Identity
- Trade Name
- ILUX SMART (2W 650nm) EUDAMEDiLux LF R2 FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- ILUX LF R2 EUDAMEDThe device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis. It is also indicated for promoting relaxation of the muscle tissue and for temporarily increasing local blood circulation. FDA UDI
- Model / Reference
- ILUX LF R2 EUDAMED10LFR2 EUDAMED1LFR2 FDA UDI
- Description
- The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis. It is also indicated for promoting relaxation of the muscle tissue and for temporarily increasing local blood circulation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08051499971595 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08051499971595 EUDAMED
- FDA Product Code
- ILY FDA UDI
- EMDN Code
- Z120615 THERAPEUTIC LASERS EUDAMED
- GMDN Term
- Musculoskeletal/physical therapy laser, professional 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Musculoskeletal/physical therapy laser, professional
iLux LF R2 by Mectronic Medicale Srl — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Mectronic Medicale Srl
Sources (2)
- FDA UDI 393ee38e-a0a0-4520-ba2e-438e3ccb72e4 33 fields · synced Jun 18, 2026
- EUDAMED 372d032b-5fac-49ff-b96f-f22a1ea8c723 61 fields · synced Jun 18, 2026