The following data is part of a premarket notification filed by Shenzhen Kaiyan Medical Co Ltd with the FDA for Demarkq Wow, Demarkq Pop.
| Device ID | K203214 |
| 510k Number | K203214 |
| Device Name: | DemarkQ WOW, DemarkQ POP |
| 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 | 2020-11-02 |
| Decision Date | 2021-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08720299044227 | K203214 | 000 |