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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 For Removal
510(k) Number K254135
Device Name LipoSurg ARTIST
Applicant
NOUVAG AG
St. Gallerstrasse 25
Goldach
Sankt Gallen,  CH 9403
Applicant Contact Christof Künz
Correspondent
Ken Block Consulting, LLC
3400 Central Expy., Suite 100-265
Richardson,  TX  75080
Correspondent Contact Kenneth Block
Regulation Number878.5040
Classification Product Code
QPB  
Date Received12/22/2025
Decision Date 09/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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