
Us Medical Innovations, LLC
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Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) is an FDA 510(k)-cleared medical device (K240297) manufactured by Us Medical Innovations, 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 May 2, 2024. Regulation: 8.