MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)

MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) is an FDA 510(k)-cleared medical device (K250195) manufactured by Matelaser, 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 May 29, 2025. Regulation: 8.