The following data is part of a premarket notification filed by Shenzhen Goodwind Technology Development Co., Ltd with the FDA for Ipl Hair Removal Device.
| Device ID | K222316 |
| 510k Number | K222316 |
| Device Name: | IPL Hair Removal Device |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Goodwind Technology Development CO., LTD 4th&5Th Floor,2nd Part Of Building A1, Yinlong Industrial Park, Gate 292, Longgang Section Of Sh Shenzhen, CN 518116 |
| Contact | Ziming Yang |
| 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 | 2022-08-02 |
| Decision Date | 2022-09-28 |