
Fibra Sonics, Inc.
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FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 is an FDA 510(k)-cleared medical device (K993046) manufactured by Fibra Sonics, 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 November 21, 1999. Regulation: 8.