FDA 510(k) Application Details - K243085

Device Classification Name	Light Based Over-The-Counter Hair Removal   More FDA Info for this Device
510(K) Number	K243085
Device Name	Light Based Over-The-Counter Hair Removal
Applicant	Zhuzhou Goldenhot Medical Technology Co.,Ltd. Room 301, Plant C-3, Phase 5, Xinma Power Innovation Park, No. 889, Xianyue huan Road, Majiahe Street,Tianyuan District Zhuzhou 412000 CN Other 510(k) Applications for this Company
Contact	Xianwu 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	09/30/2024
Decision Date	12/21/2024
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