Light Based Over the Counter Wrinkle Reduction
The FDA filing names the LED light therapy mask models FM-01, FM-02 and FM-03, including the FM-02 model in this listing. For the listed mask family, the filing identifies red light for…
The FDA filing names the LED light therapy mask models FM-01, FM-02 and FM-03, including the FM-02 model in this listing.
For the listed mask family, the filing identifies red light for full-face wrinkles and blue light for mild to moderate inflammatory acne.
Listed Item
FM-02 ; LED light therapy mask
Model Details
The filing gives the FM-02 mask dimensions as 198 by 383 by 33.5 millimetres. It separately identifies infrared light for topical heating, with stated uses that include arthritis and muscle spasm.
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 | Guangdong Newdermo Biotech 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 |
| 510(k) | K223544 |
| Record published | 2025-09-26 |
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 |
| Storage | Storage environment humidity 0 to 85 % RH; Storage environment temperature -10 to 50 °C |
| Packaging | Outer packing of 12, outer packing of 10, outer of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FM-02 | In distribution | |
| FM-02 | In distribution | |
| FM-02 | In distribution | |
| FM-01 | In distribution | |
| FM-02 | In distribution | |
| FM-03 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LED Light Therapy Mask | Shenzhen Rainbow Technology Co., Ltd. | 16 |
| 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 |
| 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 |
|---|---|
| K261052 | 2026-06-29 |
| K260946 | 2026-06-18 |
| K260202 | 2026-03-23 |
| K223544 | 2023-02-23 |
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.