Optilume® High Pressure Urological Balloon Dilation Catheter

Optilume® High Pressure Urological Balloon Dilation Catheter is an FDA 510(k)-cleared medical device (K250910) manufactured by Urotronic, Inc.. 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 May 21, 2025. Regulation: 8.