The following data is part of a premarket notification filed by Shen Zhen Cosbeauty Co., Ltd with the FDA for Ipl Hair Removal Device Joy Version.
Device ID | K173813 |
510k Number | K173813 |
Device Name: | IPL Hair Removal Device Joy Version |
Classification | Light Based Over-the-counter Hair Removal |
Applicant | Shen Zhen CosBeauty Co., Ltd UnitA-3F, Qiao De Industrial Park, Tian Liao, GuangMing District Shenzhen, CN |
Contact | Nicole Hu |
Correspondent | Iris Fung SGS-CSTC Standards Technical Services Co., Ltd. 198 KEZHU Road, SCIENTECH Park Guangzhou Guangzhou, CN |
Product Code | OHT |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-15 |
Decision Date | 2018-09-07 |
Summary: | summary |