Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)

Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) is an FDA 510(k)-cleared medical device (K253391) manufactured by Medtronic Navigation, Inc.. 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, 2026. Regulation: 8.