Espada Acne-Clearing Blue Light Pen
The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.
59manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
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 | Foreo Inc, United States |
|---|---|
| FDA product code | OLP |
| Device type | Over-The-Counter Powered Light Based Laser For Acne |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Complaint-file establishment |
| 510(k) | K162450 |
| Record published | 2017-01-09 |
| Record revised | 2022-12-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ESPADA Magenta | In distribution | |
| ESPADA Cobalt Blue | In distribution | |
| ESPADA Pink | 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 2 | Foreo Inc | 3 |
| Renpho Rejuven | Joicom Corporation | 2 |
| Espada 2 Plus | Foreo Inc | 2 |
| l.a.b. Light Activated Beauty® | LED Technologies, Inc. | 2 |
Showing 12 of 62. All products under Over-The-Counter Powered Light Based Laser For Acne
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162450 | 2016-11-30 |
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.