
Balt USA, LLC
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Optima Coil System (OptiOne Coil System) is an FDA 510(k)-cleared medical device (K254221) manufactured by Balt USA, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 26, 2026. Regulation: 8.

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