iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses is an FDA 510(k)-cleared medical device (K183200) manufactured by C&E GP Specialist, 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 January 8, 2019. Regulation: 8.