Identity
- Trade Name
- FOTONMEDIX FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- Near Infrared phototherapy device emitting up to 45 W at 980 nm, 12.1 Inch LCD Touch Screen display FDA UDI
- Model / Reference
- LaserMedix4500U1 FDA UDI
- Description
- Near Infrared phototherapy device emitting up to 45 W at 980 nm, 12.1 Inch LCD Touch Screen display FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976487170007 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Musculoskeletal/physical therapy laser, professional 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
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
Fotonmedix by Fotonmedix Medical Laser Co., LTD — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fotonmedix Medical Laser Co., LTD
Sources (1)
- FDA UDI e705cafb-433a-4de4-8289-22e3a14b32c2 33 fields · synced May 30, 2026