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…

Registry build 21.09.26

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.

67manufacturers in China registered for this device type
16catalogue numbers in this listing
2510(k) clearances naming this product code

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.

Chinese manufacturers registered for FDA product code OHS
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

Regulatory record for LED Light Therapy Mask
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

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 numbers for LED Light Therapy Mask
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

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer