VISI-SPEAR EYE SPONGE

VISI-SPEAR EYE SPONGE is an FDA 510(k)-cleared medical device (K933872) manufactured by Visitec Co.. 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 26, 1993. Regulation: 8.