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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Microneedle Device
510(k) Number K200044
Device Name SkinStylus SteriLock MicroSystem
Applicant
Esthetic Education, LLC
7950 E. Acoma Dr. Suite 100
Scottsdale,  AZ  85260
Applicant Contact Marc C. Sanchez
Correspondent
Contract In-House Counsel and Consultants, LLC
(D/B/A Fda Atty)
53516 Bickett
Cahpel Hill,  NC  27517
Correspondent Contact Marc C. Sanchez
Regulation Number878.4430
Classification Product Code
QAI  
Date Received01/08/2020
Decision Date 04/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT03366194
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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