DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) is an FDA 510(k)-cleared medical device (K210664) 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 July 26, 2021. Regulation: 8.