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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lipoaspirate washing system for aesthetic body contouring
510(k) Number BK220668
Tradename VorFat System
Device Name Lipoaspirate washing system for aesthetic body contouring
Original Applicant
Alma Lasers, Inc
485 half day rd
suite 100
buffalo grove,  IL  60089
Regulation Number878.5040
Classification Product Code
QKL  
Date Received01/25/2022
Decision Date 06/12/2023
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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