FDA 510(k) Application Details - K190555

Device Classification Name	More FDA Info for this Device
510(K) Number	K190555
Device Name	PowerX Lipo System
Applicant	Solta Medical 11720 North Creek Pkway N. Suite 100 Bothell, WA 98011 US Other 510(k) Applications for this Company
Contact	Manal Morcos Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2019
Decision Date	05/01/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review