FDA 510(k) Application Details - K212881

Device Classification Name	Light Based Over-The-Counter Hair Removal   More FDA Info for this Device
510(K) Number	K212881
Device Name	Light Based Over-The-Counter Hair Removal
Applicant	Shenzhen Fansizhe Science And Technology Co., Ltd 2nd and 3rd floors, No. 17, Xinfa 2nd Road, Xinqiao Community, Xinqiao Street, Baoan District Shenzhen 518125 CN Other 510(k) Applications for this Company
Contact	Cheng Endang 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	09/10/2021
Decision Date	04/11/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review