Identity
- Trade Name
- LED Light Therapy Mask FDA UDI
- Generic Name
- Blue/red/infrared phototherapy lamp FDA UDI
- Device Name
- - Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. - Blue light: Treatment of mild to moderate inflammatory acne. FDA UDI
- Model / Reference
- RB-030 FDA UDI
- Description
- - Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. - Blue light: Treatment of mild to moderate inflammatory acne. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16978368600303 FDA UDI
- 510(k) Number
- K243423 FDA UDI
- FDA Product Code
- OHS FDA UDIOLP FDA UDIILY FDA UDI
- GMDN Term
- Blue/red/infrared phototherapy lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI890.5500 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blue/red/infrared phototherapy lamp
LED Light Therapy Mask by Shenzhen Rainbow Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K243423 also covers:
- LED Light Therapy Mask — Shenzhen Rainbow Technology Co., Ltd.
- LED Light Therapy Mask — Shenzhen Rainbow Technology Co., Ltd.
- LED Light Therapy Mask — Shenzhen Rainbow Technology Co., Ltd.
- LED Light Therapy Mask — Shenzhen Rainbow Technology Co., Ltd.
- LED Light Therapy Mask — Shenzhen Rainbow Technology Co., Ltd.
- LED Light Therapy Mask — Shenzhen Rainbow Technology Co., Ltd.
- LED Light Therapy Mask — Shenzhen Rainbow Technology Co., Ltd.
- LED Light Therapy Mask — Shenzhen Rainbow Technology Co., Ltd.
- LED Light Therapy Mask — Shenzhen Rainbow Technology Co., Ltd.
- LED Light Therapy Mask — Shenzhen Rainbow Technology Co., Ltd.
- LED Light Therapy Mask — Shenzhen Rainbow Technology Co., Ltd.
- LED Light Therapy Mask - HIME SAMA — Shenzhen Rainbow Technology Co., Ltd.
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 Rainbow Technology Co., Ltd.
Sources (1)
- FDA UDI dae4bedd-30d4-439f-9262-5d6748c37b97 34 fields · synced Jun 8, 2026