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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 K241355
Device Name SER Pen Carain MicroSystem (MP1209SP)
Applicant
Su-Ko Technologies, LLC
700 Smith St., #61070
Houston,  TX  77002
Applicant Contact Yuan Yuan "Susie" Su Korrodi
Correspondent
Contract In-House Counsel and Consultants,
Llc D/B/A Fda Atty
1717 Pennsylvania Ave. NW Suite 1025
Washington,  DC  20006
Correspondent Contact Marc Sanchez, Esq.
Regulation Number878.4430
Classification Product Code
QAI  
Date Received05/14/2024
Decision Date 10/09/2024
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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