FDA 510(k) Application Details - K243040

Device Classification Name	Light Based Over The Counter Wrinkle Reduction   More FDA Info for this Device
510(K) Number	K243040
Device Name	Light Based Over The Counter Wrinkle Reduction
Applicant	Shenzhen Siken 3D Technology Development Co., Ltd. 4th Building,No.33 Left East Avenue,Songgang, Bao'an District Shenzhen 518105 CN Other 510(k) Applications for this Company
Contact	Liu Jing Quan 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	09/27/2024
Decision Date	12/20/2024
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