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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suction, Lipoplasty
510(k) Number K171135
Device Name Lipogems System
Applicant
Lipogems International Spa
Viale Bianca Maria 24
Milano,  IT 20129
Applicant Contact Carlo Russo
Correspondent
Bruder Consulting International, LLC
268 Glen Pl.
Franklin Lakes,  NJ  07417
Correspondent Contact Scott Bruder
Regulation Number878.5040
Classification Product Code
MUU  
Date Received04/17/2017
Decision Date 05/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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