Optima Coil System (OptiOne Coil System)

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.