Oculeve Intranasal Tear Neurostimulator Device

Oculeve Intranasal Tear Neurostimulator Device is an FDA 510(k)-cleared medical device (DEN160030) manufactured by Oculeve, 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 April 23, 2017. Regulation: 8.