OCTAX LASER SHOT SYSTEM

OCTAX LASER SHOT SYSTEM is an FDA 510(k)-cleared medical device (K062524) manufactured by Minitube of America, Inc.. 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 December 14, 2006. Regulation: 8.