
F Care Systems USA, LLC
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F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) is an FDA 510(k)-cleared medical device (K252704) manufactured by F Care Systems USA, 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 November 23, 2025. Regulation: 8.