HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)

HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) is an FDA 510(k)-cleared medical device (DEN040009) manufactured by Hamilton Thorne Biosciences. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 3, 2004. Regulation: 8.