The following data is part of a premarket notification filed by Beijing Honkon Technologies Co., Ltd with the FDA for Slimming Treatment Device.
Device ID | K161892 |
510k Number | K161892 |
Device Name: | Slimming Treatment Device |
Classification | Massager, Vacuum, Light Induced Heating |
Applicant | BEIJING HONKON TECHNOLOGIES CO., LTD 72 Bldg., Golden Bridge S&T Indus. Base, 16# Huanke Mid RD. Tongzhou Dist. Beijing, CN 101102 |
Contact | Li Yanzhe |
Correspondent | Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd. LiYuan Town, TongZhou Beijing, CN 101121 |
Product Code | NUV |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-07-11 |
Decision Date | 2017-03-02 |
Summary: | summary |