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510(k) K190555

PowerX Lipo System by Solta Medical — Product Code QPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2019
Date Received
March 5, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Suction, Lipoplasty For Removal
Device Class
Class II
Regulation Number
878.5040
Review Panel
SU
Submission Type

A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring

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