Identity
- Trade Name
- SOLAWAVE FDA UDI
- Generic Name
- Blue/red/infrared phototherapy lamp FDA UDI
- Device Name
- The LED Eye Mask, model: EY-20N is an over-the-counter light-emiting diode (LEDdevice that emits energy for dermatology to treat wrinkles within the periorbital region. The device usesfour types of LEDs is 605nm, 633nm, 660nm, 830nm. The LED Eye Mask components contain the mainunit, USB cable cord and velcro straps and removable eye protection. There is a total of 40 LEDs toprovide a power intensity of about 65 mW/cm?. The device has only one button to turn on/off.The user wears the device on their eye area for the treatment, and the device will shut down automatically FDA UDI
- Model / Reference
- EY-20N FDA UDI
- Description
- The LED Eye Mask, model: EY-20N is an over-the-counter light-emiting diode (LEDdevice that emits energy for dermatology to treat wrinkles within the periorbital region. The device usesfour types of LEDs is 605nm, 633nm, 660nm, 830nm. The LED Eye Mask components contain the mainunit, USB cable cord and velcro straps and removable eye protection. There is a total of 40 LEDs toprovide a power intensity of about 65 mW/cm?. The device has only one button to turn on/off.The user wears the device on their eye area for the treatment, and the device will shut down automatically FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810137610429 FDA UDI
- 510(k) Number
- K233556 FDA UDI
- FDA Product Code
- OHS FDA UDI
- GMDN Term
- Blue/red/infrared phototherapy lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blue/red/infrared phototherapy lamp
Solawave by Shenzhen Kaiyan Medical Equipment Co, . Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K233556 also covers:
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
- Shenzhen Kaiyan Medical Equipment Co, . Ltd
Sources (1)
- FDA UDI c6e5bc9a-6330-409f-a2b0-278e93a6b033 34 fields · synced May 30, 2026