LumiRex Bronchoscope

LumiRex Bronchoscope is an FDA 510(k)-cleared medical device (K243541) manufactured by Contra Healthcare Solutions, LLC. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 2025. Regulation: 8.