FSYX Ocular Pressure Adjusting Pump

FSYX Ocular Pressure Adjusting Pump is an FDA 510(k)-cleared medical device (K252455) manufactured by Balance Ophthalmics, 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 29, 2026. Regulation: 8.