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, Ai06, Ai08, Ai16, Ai17.
| Device ID | K221466 |
| 510k Number | K221466 |
| Device Name: | IPL Hair Removal Device, Model: AI01, AI06, AI08, AI16, AI17 |
| 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.406, Building C, Run Science Park, No.18 Shenzhou Road, Huangpu Guangzhou, CN 510663 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-19 |
| Decision Date | 2022-08-12 |