The following data is part of a premarket notification filed by Shenzhen Century Dongyuan Technology Co Ltd. with the FDA for Ipl Hair Removal Device, Model: Ai01.
| Device ID | K212897 |
| 510k Number | K212897 |
| Device Name: | IPL Hair Removal Device, Model: AI01 |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Century Dongyuan Technology Co Ltd. Floor 2, Building B1, Gonghe Fourth Industrial Zone, Shajing Street, Bao'an District Shenzhen, CN 518104 |
| Contact | He Wang |
| Correspondent | You Yijie Qimmiq Medical Consulting Service Co., Ltd. Rm.1711, Building K, No.101 Science Ave International Creative Valley Guangzhou, CN 510663 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-10 |
| Decision Date | 2021-11-04 |