Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens

Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens is an FDA 510(k)-cleared medical device (K170335) manufactured by Valley Contax, 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 March 23, 2017. Regulation: 8.