FDA 510(k) Application Details - K221363

Device Classification Name	More FDA Info for this Device
510(K) Number	K221363
Device Name	AF Laser
Applicant	ShenB Co Ltd ShenB Bldg 148 Seongsui-ro Seoul 04796 KR Other 510(k) Applications for this Company
Contact	Sunny Kang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2022
Decision Date	07/20/2022
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