FDA 510(k) Application Details - K213285

Device Classification Name	Light Based Over The Counter Wrinkle Reduction   More FDA Info for this Device
510(K) Number	K213285
Device Name	Light Based Over The Counter Wrinkle Reduction
Applicant	Y & J Bio Co., Ltd. B-916, 947, Hanam-daero Hanam-si 12982 KR Other 510(k) Applications for this Company
Contact	Chun Young Sam 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	10/01/2021
Decision Date	03/03/2022
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