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 - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment. FDA UDI
- Model / Reference
- RB-008JB FDA UDI
- Description
- - Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16978368600044 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
Similar devices
Also classified as Blue/red/infrared phototherapy lamp.
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- LESCOLTON — Shenzhen Lescolton Medical Equipment Co., Ltd. · Class II
- Platinum LED Therapy Lights — PLATINUM LED HOLDINGS LLC · Class II
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 89f84f2c-95b6-4942-ad1a-a6e2f3a2160e 34 fields · synced May 31, 2026