The following data is part of a premarket notification filed by Guangzhou Haoxingwan Technology Co., Ltd. with the FDA for Superior Hair Remover.
Device ID | K210376 |
510k Number | K210376 |
Device Name: | Superior Hair Remover |
Classification | Light Based Over-the-counter Hair Removal |
Applicant | Guangzhou Haoxingwan Technology Co., Ltd. Room 718, No.9, Linhe West Road, Tianhe District Guangzhou, CN 510000 |
Contact | Chun Tao |
Correspondent | Iris Wang Shenzhen Joyantech Consulting Co.,Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xil Town 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 | 2021-02-09 |
Decision Date | 2021-10-07 |