LumiRex Ureteroscope

LumiRex Ureteroscope is an FDA 510(k)-cleared medical device (K243532) manufactured by Contra Healthcare Solutions, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 27, 2025. Regulation: 8.