iTEAR100 Neurostimulator

iTEAR100 Neurostimulator is an FDA 510(k)-cleared medical device (K213623) manufactured by Olympic Ophthalmics. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 15, 2022. Regulation: 8.