FDA 510(k) Application Details - K212314

Device Classification Name	Light Based Over-The-Counter Hair Removal   More FDA Info for this Device
510(K) Number	K212314
Device Name	Light Based Over-The-Counter Hair Removal
Applicant	Zhongshan Bisen Plastic Electronic Products Co., Ltd. Second Floor, A Building, No.32 JianYe Road, Torch Development Zone Zhongshan 528437 CN Other 510(k) Applications for this Company
Contact	Rao Guanhua 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	07/23/2021
Decision Date	10/21/2021
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