LIPIFLOW THERMAL PULSATION SYSTEM

LIPIFLOW THERMAL PULSATION SYSTEM is an FDA 510(k)-cleared medical device (K112704) manufactured by Tearscience, 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 December 18, 2011. Regulation: 8.