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Ulthera, Inc.
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ULTHERA SYSTEM, MODEL 8850-0001 is an FDA 510(k)-cleared medical device (DEN080006) manufactured by Ulthera, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 2009. Regulation: 8.