SOF-SUCTION FLUID EVACUATION SYSTEM

SOF-SUCTION FLUID EVACUATION SYSTEM is an FDA 510(k)-cleared medical device (K990749) manufactured by X-Tech Medical, LLC. 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 1, 1999. Regulation: 8.