SUS (STENFILCON A) CONTACT LENS

SUS (STENFILCON A) CONTACT LENS is an FDA 510(k)-cleared medical device (K131378) manufactured by CooperVision, 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 August 29, 2013. Regulation: 8.