FDA 510(k) Application Details - K211402

Device Classification Name	More FDA Info for this Device
510(K) Number	K211402
Device Name	Powersculp laser lipolysis system
Applicant	Lotuxs Medtech (Suzhou) Co., Ltd. RM301, NW-06, Nanopolis Suzhou, 99 Jinji Lake Avenue, Suzhou Industry Suzhou 215123 CN Other 510(k) Applications for this Company
Contact	Na Wu 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	05/06/2021
Decision Date	07/30/2021
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