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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 BK190433
Tradename AuraGen 1-2-3™ with AuraClens™ Suction Lipoplasty System (A123+ AuraClens)
Device Name Lipoaspirate washing system for aesthetic body contouring
Original Applicant
Tiger Aesthetics Medical, LLC
9779 s. franklin dr.
suite #300
franklin,  WI  53132
Regulation Number878.5040
Classification Product Code
QKL  
Date Received12/16/2019
Decision Date 03/13/2020
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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