
Su-Ko Technologies, LLC
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SER Pen Carain MicroSystem (MP1209SP) is an FDA 510(k)-cleared medical device (K253153) manufactured by Su-Ko Technologies, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 28, 2025. Regulation: 8.