iStent infinite Trabecular Micro-Bypass System, Model iS3

iStent infinite Trabecular Micro-Bypass System, Model iS3 is an FDA 510(k)-cleared medical device (K220032) manufactured by Glaukos Corporation. 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 1, 2022. Regulation: 8.