REVOLVE ENVI 600 Advanced Adipose System

System, Suction, Lipoplasty

LifeCell Corporation

The following data is part of a premarket notification filed by Lifecell Corporation with the FDA for Revolve Envi 600 Advanced Adipose System.

Pre-market Notification Details

Device IDK193539
510k NumberK193539
Device Name:REVOLVE ENVI 600 Advanced Adipose System
ClassificationSystem, Suction, Lipoplasty
Applicant LifeCell Corporation One Millennium Way Branchburg,  NJ  08876
ContactBozhana Hegarty
CorrespondentBozhana Hegarty
LifeCell Corporation One Millennium Way Branchburg,  NJ  08876
Product CodeMUU  
CFR Regulation Number878.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-05-28

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