EYE-CEPT STERILE SALINE SOLUTION

EYE-CEPT STERILE SALINE SOLUTION is an FDA 510(k)-cleared medical device (K110221) manufactured by Optics Laboratory, 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 October 31, 2011. Regulation: 8.