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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 BK220720
Tradename Dermapose Refresh (K193363)
Device Name Lipoaspirate washing system for aesthetic body contouring
Original Applicant
Puregraft LLC
420 stevens ave
suite 220
solana beach,  CA  92075
Regulation Number878.5040
Classification Product Code
QKL  
Date Received04/06/2022
Decision Date 04/14/2020
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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