CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)

CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) is an FDA 510(k)-cleared medical device (K133466) manufactured by Mauna Kea Technologies. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 24, 2014. Regulation: 8.