Benilight
- Primary DI
- 08809922440053
- Brand
- Benilight
- Company
- Benilight
- Model
- iLED-Pro Mini
- Device 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), 850nm (NIR), and 940nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light.
- Published
- 2024-10-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Related Records
Contact Domains
Product Codes
| Code | Name |
|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08809922440053 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08809922440053 | 08809922440053 | 8809922440053 |
GMDN Terms
| Term | Definition |
|---|---|
| Red/infrared light phototherapy unit | An electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +821037229599 | slim@benilight.com |
Regulatory Flags
- DUNS number
- 695132580
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08809922440060 | Benilight | Life Beam | 2025-04-03 | |
| 08809922440039 | Benilight | iLED-Pro | 2024-10-01 | |
| 08809922440046 | Benilight | iLED | 2024-10-01 |
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