FDA 510(k) Application Details - K201731

Device Classification Name	More FDA Info for this Device
510(K) Number	K201731
Device Name	Diode Laser Body Sculpture System
Applicant	Shanghai Apolo Medical Technology Co., Ltd. Room 301-310, Building 11, No.388, Yindu Road, Xuhui District Shanghai 200231 CN Other 510(k) Applications for this Company
Contact	Felix Li Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/24/2020
Decision Date	09/10/2020
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