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 |