
American Medical Systems, Inc.
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ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 is an FDA 510(k)-cleared medical device (K790519) manufactured by American Medical Systems, 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 13, 1979. Regulation: 8.