FDA 510(k) Application Details - K162489

Device Classification Name	Light Based Over The Counter Wrinkle Reduction   More FDA Info for this Device
510(K) Number	K162489
Device Name	Light Based Over The Counter Wrinkle Reduction
Applicant	Zhongshan Bisen Plastic Electronic Products Co.,Ltd. F2,Bldg1,No.8,Dongzhen North Rd,Zhangjiabian 1st vil Torch Development Zone Zhong Shan 528437 CN Other 510(k) Applications for this Company
Contact	FengPing Li Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OHS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2016
Decision Date	01/13/2017
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