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 |