TXCELL SCANNING LASER DELIVERY SYSTEM

TXCELL SCANNING LASER DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K121475) manufactured by Iridex Corp. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 27, 2012. Regulation: 8.