ICEfx Cryoablation System (FPRCH8000-02)

ICEfx Cryoablation System (FPRCH8000-02) is an FDA 510(k)-cleared medical device (K234002) manufactured by Boston Scientific. 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 March 12, 2024. Regulation: 8.