The following data is part of a premarket notification filed by Shenzhen Borria Technology Co.,ltd with the FDA for Ipl Hair Removal Machine.
| Device ID | K213020 |
| 510k Number | K213020 |
| Device Name: | IPL Hair Removal Machine |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Borria Technology Co.,Ltd 22A, Tianmian City Building, No.4026 Shennan Middle Road, Tianmian Community, Huafu Street, Futian District Shenzhen, CN 518000 |
| Contact | Li Zhenqiang |
| Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Rm 2401 ZhenYe International Center, No. 3101-90 Qianhai Road, Nanshan District 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 | 2021-09-20 |
| Decision Date | 2021-12-16 |