The following data is part of a premarket notification filed by Shenzhen Kaiyan Medical Co Ltd with the FDA for Aduro Light Beauty Mask.
| Device ID | K202390 |
| 510k Number | K202390 |
| Device Name: | Aduro Light Beauty Mask |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | Shenzhen Kaiyan Medical Co Ltd 40A Fuxin Road, Fuyong Subdistrict, BaoAn District Shenzhen, CN 518101 |
| Contact | Alain Dijkstra |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, CN 510006 |
| Product Code | OHS |
| Subsequent Product Code | ILY |
| Subsequent Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-21 |
| Decision Date | 2021-07-14 |