
Notal Vision, Inc.
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Notal Vision Home Optical Coherence Tomography (OCT) System is an FDA 510(k)-cleared medical device (DEN230043) manufactured by Notal Vision, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 14, 2024. Regulation: 8.