510(k) K220032

iStent infinite Trabecular Micro-Bypass System, Model iS3 by Glaukos Corporation — Product Code KYF

K220032 is an FDA 510(k) premarket notification submitted by Glaukos Corporation for the device "iStent infinite Trabecular Micro-Bypass System, Model iS3". The FDA issued a decision of Substantially Equivalent on August 2, 2022. The device falls under product code KYF (Implant, Eye Valve), a Class II device regulated under 21 CFR 886.3920.