The following data is part of a premarket notification filed by Shenzhen Kaiyan Medical Co Ltd with the FDA for Oren Led Perioral Light Therapy System.
| Device ID | K213024 |
| 510k Number | K213024 |
| Device Name: | Oren LED Perioral Light Therapy System |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| 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 | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-21 |
| Decision Date | 2021-12-22 |