ILUMIEN, Drageonfly OPTIS Imaging Catheter

ILUMIEN, Drageonfly OPTIS Imaging Catheter is an FDA 510(k)-cleared medical device (K150237) manufactured by Lightlab Imaging, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 4, 2015. Regulation: 8.