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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 K241400
Device Name SkinPen Precision Elite System
Applicant
Crown Aesthetics
5005 Lyndon B. Johnson Frwy, Suite 370
Dallas,  TX  75244
Applicant Contact Marie Fogartie
Correspondent
Crown Aesthetics
5005 Lyndon B. Johnson Frwy, Suite 370
Dallas,  TX  75244
Correspondent Contact Marie Fogartie
Regulation Number878.4430
Classification Product Code
QAI  
Date Received05/17/2024
Decision Date 08/29/2024
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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