LensGiene Sterile Saline Solution

LensGiene Sterile Saline Solution is an FDA 510(k)-cleared medical device (K161622) 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 August 10, 2016. Regulation: 8.