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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 K243800
Device Name PRO Pen Microneedling System (6883)
Applicant
Dermalogica, LLC
1535 Beachey Pl.
Carson,  CA  90746
Applicant Contact Nelson Torres
Correspondent
Dermalogica, LLC
1535 Beachey Pl.
Carson,  CA  90746
Correspondent Contact Nelson Torres
Regulation Number878.4430
Classification Product Code
QAI  
Date Received12/11/2024
Decision Date 08/25/2025
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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