Identity
- Trade Name
- TRUDERMAL FDA UDI
- Generic Name
- Cosmetic red-light phototherapy system, home-use FDA UDI
- Device Name
- The LED Light Therapy Mask (Models: MK66-H) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask (Models: MK66-H) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles. FDA UDI
- Model / Reference
- MK66-H FDA UDI
- Description
- The LED Light Therapy Mask (Models: MK66-H) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask (Models: MK66-H) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970006970703 FDA UDI
- FDA Product Code
- OHS FDA UDIOLP FDA UDI
- GMDN Term
- Cosmetic red-light phototherapy system, home-use 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
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cosmetic red-light phototherapy system, home-use
Trudermal by Shenzhen Kaiyan Medical Equipment 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
- Shenzhen Kaiyan Medical Equipment Co, . Ltd
Sources (1)
- FDA UDI ce24912f-219d-4c8f-9a46-772458bdf871 33 fields · synced May 30, 2026