LEICA COLPOSCOPE

LEICA COLPOSCOPE is an FDA 510(k)-cleared medical device (K000707) manufactured by Leica Microscopy Systems , Ltd.. 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 June 26, 2000. Regulation: 8.