FDA 510(k) Application Details - K240016

Device Classification Name Light Based Over-The-Counter Hair Removal

  More FDA Info for this Device
510(K) Number K240016
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Jianrong Biomedical Electronics Co., Ltd
Floor 4, Building 3, Haoer Jiashitai Industrial Park, No.164
Fengtang Avenue, Zhancheng Community, Fuhai Street, Bao'an D
Shenzhen 518103 CN
Other 510(k) Applications for this Company
Contact Bruce Liu
Other 510(k) Applications for this Contact
Regulation Number 878.4810

  More FDA Info for this Regulation Number
Classification Product Code OHT
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 01/02/2024
Decision Date 07/10/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240016


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact