FDA 510(k) Application Details - K200983

Device Classification Name	Light Based Over The Counter Wrinkle Reduction   More FDA Info for this Device
510(K) Number	K200983
Device Name	Light Based Over The Counter Wrinkle Reduction
Applicant	Ningbo Hesi Electric Co., Ltd No.818-23-156 Qiming Rd, Yinzhou, Ningbo City Zhejiistrict, Ningbo, Zhejiang, Ningbo 315000 CN Other 510(k) Applications for this Company
Contact	Ma LuLu 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	04/14/2020
Decision Date	07/14/2021
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