Stone Clear (SC-LP9-01)

Stone Clear (SC-LP9-01) is an FDA 510(k)-cleared medical device (DEN230082) manufactured by Sonomotion, 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 October 29, 2024. Regulation: 8.