
Nova Eye Inc. (Business Name Nova Eye Medical)
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ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System is an FDA 510(k)-cleared medical device (K221872) manufactured by Nova Eye Inc. (Business Name Nova Eye Medical). This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 2023. Regulation: 8.