VASERlipo System

System, Suction, Lipoplasty

Solta Medical

The following data is part of a premarket notification filed by Solta Medical with the FDA for Vaserlipo System.

Pre-market Notification Details

Device IDK190551
510k NumberK190551
Device Name:VASERlipo System
ClassificationSystem, Suction, Lipoplasty
Applicant Solta Medical 11720 North Creek Pkwy N., Suite 100 Bothell,  WA  98011
ContactManal Morcos
CorrespondentManal Morcos
Manal Morcos, MS BME, MBA 400 Somerset Corporate Boulevard Bridgewater,  NJ  08807
Product CodeMUU  
CFR Regulation Number878.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-05
Decision Date2019-05-01

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