Shani Darden LED Light Therapy Mask
Shani Darden Branded Facemask Blue, Red & NIR facemask
59manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (50), Zhejiang (3), Fujian (2). 11 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 Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Zhangzhou Easepal Medical Science AND Technology Co., Ltd. | Zhangzhou | Fujian | Contract manufacturer | 8 |
| Gymmax Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Xuzhou Kernel Medical Equipment Co Ltd | Xuzhou | Jiangsu | Contract manufacturer | 7 |
| 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 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
Showing 12 of 59. All 59 manufacturers in China registered for Over-The-Counter Powered Light Based Laser For Acne
Record
| Listed by | I-Smart Developments Limited |
|---|---|
| FDA product code | OLP |
| Device type | Over-The-Counter Powered Light Based Laser For Acne |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| 510(k) | K214103 |
| Record published | 2022-03-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -25 to 5 °C; Storage environment humidity 20 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TN2118 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Celluma | Biophotas, Inc. | 19 |
| PMD | Dongguan Hunter Electronic Technology Co., Ltd. | 10 |
| Jianchao Smart | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 6 |
| reVive Light Therapy® | LED Technologies, Inc. | 6 |
| Neutrogena | Kenvue Brands LLC | 6 |
| Nuon | Shenzhen Nuon Medical Equipment Co., Ltd. | 5 |
| Me | Tanda Beauty Canada, Inc. | 5 |
| Over-The-Counter Powered Light Based Laser For Acne | Shenzhen Osto Medical Technology Company Limited | 4 |
| Espada Acne-Clearing Blue Light Pen | Foreo Inc | 3 |
| Espada 2 | Foreo Inc | 3 |
| Renpho Rejuven | Joicom Corporation | 2 |
| Espada 2 Plus | Foreo Inc | 2 |
Showing 12 of 62. All products under Over-The-Counter Powered Light Based Laser For Acne
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.