INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS

INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS is an FDA 510(k)-cleared medical device (K023182) manufactured by Ethicon Endo-Surgery, Inc.. 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 October 23, 2002. Regulation: 8.