FDA 510(k) Application Details - K191068

Device Classification Name	More FDA Info for this Device
510(K) Number	K191068
Device Name	Powersculp laser lipolysis system
Applicant	Wuhan Lotuxs Technology Co., Ltd. 5 F, E2 Building, NO 999 Gaoxin Avenue, Future City East lake High-Tech development Zone, Wu 430206 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	04/22/2019
Decision Date	07/17/2019
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