RA-308 Excimer Laser System, Excimer Laser Catheter

RA-308 Excimer Laser System, Excimer Laser Catheter is an FDA 510(k)-cleared medical device (K170349) manufactured by Ra Medical Systems,Inc. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 2017. Regulation: 8.