Visualase V2 MRI-guided Laser Ablation System (9736422)

Visualase V2 MRI-guided Laser Ablation System (9736422) is an FDA 510(k)-cleared medical device (K250307) manufactured by Medtronic Navigation. 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 28, 2025. Regulation: 8.