Identity
- Trade Name
- Benilight FDA UDI
- Generic Name
- Red/infrared light phototherapy unit FDA UDI
- Device Name
- This device is an LED phototherapy unit that is used to relieve or reduce muscle pain by illuminating infrared ray. This device comprises a controller, an LED pad, an adapter and a band. The controller is connected to the LED pad that runs for 5 minutes, 15 minutes, or 30 minutes, for LO or HI, for 500Hz, 100Hz, 40Hz, 10Hz, or 2.5Hz. The wavelengths of the unit include 660nm (red) and 850nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light. FDA UDI
- Model / Reference
- iLED FDA UDI
- Description
- This device is an LED phototherapy unit that is used to relieve or reduce muscle pain by illuminating infrared ray. This device comprises a controller, an LED pad, an adapter and a band. The controller is connected to the LED pad that runs for 5 minutes, 15 minutes, or 30 minutes, for LO or HI, for 500Hz, 100Hz, 40Hz, 10Hz, or 2.5Hz. The wavelengths of the unit include 660nm (red) and 850nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809922440046 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Red/infrared light phototherapy unit 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
No
FDA UDI
Over-the-Counter
Yes
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: Red/infrared light phototherapy unit
Benilight by Benilight — 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
- Benilight
Sources (1)
- FDA UDI 7499cf16-ac5f-4861-8031-a074584976bb 34 fields · synced May 30, 2026