About This 510(k) Submission
K240297 is an FDA 510(k) clearance for the Canady Helios Cold Plasma? XL-1000CP? Ablation System (XL-1000CPSYS), a Low Energy Direct Current Thermal Ablation System (Class II — Special Controls, product code OAB), submitted by Us Medical Innovations, LLC (Tacoma Park, US). The FDA issued a Cleared decision on May 3, 2024, 92 days after receiving the submission on February 1, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.