OPTIS Metallic Stent Optimization E.4 SW

OPTIS Metallic Stent Optimization E.4 SW is an FDA 510(k)-cleared medical device (K160878) 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 June 28, 2016. Regulation: 8.