SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS

SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS is an FDA 510(k)-cleared medical device (K051035) manufactured by Synergeyes. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 1, 2005. Regulation: 8.