LED Light Therapy Mask
This wearable LED mask applies red, blue and infrared light to the face for home phototherapy. It comprises a mask, a controller and a Type-C charging cable, with the mask placed directly…
This wearable LED mask applies red, blue and infrared light to the face for home phototherapy. It comprises a mask, a controller and a Type-C charging cable, with the mask placed directly against the skin.
Light modes vary by model. The listed RB-008G, RB-008GB, RB-008J and RB-008JB models provide red plus infrared, red, blue, and red plus blue modes. They do not have the separate infrared-only mode provided by some other models in the wider range.
Listed Item
– 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. – Red+Blue light: Treatment of mild to moderate inflammatory acne
Light Modes and Intended Uses
The LEDs use red light at 620 nm, blue light at 460 nm and infrared light at 850 nm. Red and red-plus-infrared modes are intended for full-face wrinkles; blue and red-plus-blue modes are intended for mild to moderate inflammatory acne. The mask is intended for adults in a home healthcare environment.
Who Else Makes It
Concentrated in Guangdong (57), Fujian (4), Zhejiang (2). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Shenzhen Huayan E-Commerce Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Xiamen Solex High-Tech Industries Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
| Zhangzhou Easepal Medical Science AND Technology Co., Ltd. | Zhangzhou | Fujian | Contract manufacturer | 8 |
| Gymmax Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Xiangzhida Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Shenzhen Zowee Smart Manufacturing Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Foshan Shiding Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Allbeauty Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Ningbo Yimei Nikko-Seiki Manufacture Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 3 |
| Shenzhen Azure Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
Showing 12 of 67. All 67 manufacturers in China registered for Light Based Over The Counter Wrinkle Reduction
Record
| Listed by | Shenzhen Rainbow Technology Co., Ltd., China |
|---|---|
| FDA product code | OHS |
| Device type | Light Based Over The Counter Wrinkle Reduction |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K243423 |
| Record published | 2025-06-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| RB-008JB | In distribution | ||
| RB-008GB | 10 | In distribution | |
| RB-030 | 10 | In distribution | |
| RB-053 | In distribution | ||
| RB-081 | 10 | In distribution | |
| RB-030 | In distribution | ||
| RB-008GB | In distribution | ||
| RB-053 | 6 | In distribution | |
| RB-008JB | 10 | In distribution | |
| RB-008J | In distribution | ||
| RB-008G | In distribution | ||
| RB-081 | In distribution | ||
| RB-008G | 10 | In distribution | |
| RB-061 | In distribution | ||
| RB-061 | 12 | In distribution | |
| RB-008J | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | Shenzhen Sungrow LED Technology Co., Ltd. | 13 |
| reVive Light Therapy® | LED Technologies, Inc. | 10 |
| PMD | Dongguan Hunter Electronic Technology Co., Ltd. | 10 |
| ACE-TEC | Guangdong Ace-Tec Co., Ltd. | 9 |
| Conair | Conair LLC. | 9 |
| Shark CryoGlow | Sharkninja Operating LLC | 7 |
| Celluma | Biophotas, Inc. | 6 |
| Liyoutong | Shenzhen Liyoutong Technology Co., Ltd. | 6 |
| Light Based Over The Counter Wrinkle Reduction | Guangdong Newdermo Biotech Co., Ltd. | 6 |
| Dr Dennis Gross Skincare | LED Technologies, Inc. | 6 |
| NuFACE | Nuface | 5 |
| Sunglor | Sunglor Technology Co., Ltd. | 5 |
Showing 12 of 157. All products under Light Based Over The Counter Wrinkle Reduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253712 | 2026-01-23 |
| K243423 | 2025-01-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.