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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 K142682
Device Name The Lipogems System
Applicant
Lipogems International Spa
Viale Bianca Maria 24
Milano,  IT 20129
Applicant Contact Carlo Russo
Correspondent
Donawa Lifescience Consulting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number878.5040
Classification Product Code
MUU  
Date Received09/19/2014
Decision Date 12/22/2014
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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