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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K200140
Device Name Silhouette Instalift
Applicant
Silhouette Lift, Inc.
1 Technology Dr. F211
Irvine,  CA  92618
Applicant Contact Anthony DiBernardo
Correspondent
Silhouette Lift, Inc.
1 Technology Dr. F211
Irvine,  CA  92618
Correspondent Contact Anthony DiBernardo
Regulation Number878.4493
Classification Product Code
GAM  
Date Received01/21/2020
Decision Date 03/27/2020
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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