
Ulthera, Inc.
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Ulthera System (UC-1 Control Unit PRIME Model 2.1) is an FDA 510(k)-cleared medical device (K250418) 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 May 12, 2025. Regulation: 8.