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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 K253153
Device Name SER Pen Carain MicroSystem (MP1209SP)
Applicant
Su-Ko Technologies, LLC
7801 N Lamar Blvd.
Suite F34
Austin,  TX  78752
Applicant Contact Yuan Yuan "Susie" Su Korrodi
Correspondent
Contract In-House Counsel and Consultants, LLC D/B/A FDA Att
1717 Pennsylvania Ave. NW, Suite 1025
Washington Dc,  DC  20006
Correspondent Contact Marc Sanchez
Regulation Number878.4430
Classification Product Code
QAI  
Date Received09/26/2025
Decision Date 10/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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