ISC-1000 PENTAX CONFOCAL LASER SYSTEM

ISC-1000 PENTAX CONFOCAL LASER SYSTEM is an FDA 510(k)-cleared medical device (K042740) manufactured by Pentax Medical Company. 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 October 18, 2004. Regulation: 8.