The following data is part of a premarket notification filed by Shenzhen Kaiyan Medical Co Ltd with the FDA for Aduro Light Therapy Handheld.
| Device ID | K203271 |
| 510k Number | K203271 |
| Device Name: | Aduro Light Therapy Handheld |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Shenzhen Kaiyan Medical CO LTD 40A Fuxin Road, Fuyong Subdistrict, BaoAn District Shenzhen, CN 518000 |
| Contact | Alain Dijkstra |
| Correspondent | Alain Dijkstra Shenzhen Kaiyan Medical CO LTD 40A Fuxin Road, Fuyong Subdistrict, BaoAn District Shenzhen, CN 518000 |
| Product Code | OLP |
| Subsequent Product Code | ILY |
| Subsequent Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-06 |
| Decision Date | 2021-07-21 |