Lithoblast Single Use Holmium Laser Fibers

Lithoblast Single Use Holmium Laser Fibers is an FDA 510(k)-cleared medical device (K250776) manufactured by Dawell Medical, 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 October 13, 2025. Regulation: 8.