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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name lipoaspirate washing system for aesthetic body contouring
510(k) Number BK220721
Tradename REVOLVE ENVI 600 Advanced Adipose System (K193539)
Device Name Lipoaspirate washing system for aesthetic body contouring
Original Applicant
LifeCell Corporation
one millennium way
branchburg,  NJ  08876
Regulation Number878.5040
Classification Product Code
QKL  
Date Received04/06/2022
Decision Date 05/28/2020
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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