
Stryker Instruments
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OptaBlate Radiofrequency (RF) Generator System is an FDA 510(k)-cleared medical device (K250327) manufactured by Stryker Instruments. 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 April 14, 2025. Regulation: 8.