The following data is part of a premarket notification filed by Shenzhen Siken 3d Technology Development Co., Ltd. with the FDA for Ipl Cooling Hair Removal Device.
| Device ID | K222710 |
| 510k Number | K222710 |
| Device Name: | IPL Cooling Hair Removal Device |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Siken 3D Technology Development Co., Ltd. 4th Building,No.33 Left East Avenue,Songgang, Bao'an District Shenzhen, CN 518105 |
| Contact | Jingquan Liu |
| Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Shenzhen, CN 518000 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-08 |
| Decision Date | 2022-12-01 |