Cleared Traditional

iStent infinite Trabecular Micro-Bypass System, Model iS3

K220032 · Glaukos Corporation · Ophthalmic

Aug 2022

Decision

209d

Days

Class 2

Risk

About This 510(k) Submission

K220032 is an FDA 510(k) clearance for the iStent infinite Trabecular Micro-Bypass System, Model iS3, a Implant, Eye Valve (Class II — Special Controls, product code KYF), submitted by Glaukos Corporation (San Clemente, US). The FDA issued a Cleared decision on August 2, 2022, 209 days after receiving the submission on January 5, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3920.

Submission Details

510(k) Number	K220032 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 2022
Decision Date	August 02, 2022
Days to Decision	209 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF