iStent infinite Trabecular Micro-Bypass System, Model iS3— 510(k) K220032

Name: FDA 510(k) clearance K220032
Creator: U.S. Food and Drug Administration
Published: 2022-08-02

Substantially Equivalent

Glaukos Corporation

FDA 510(k) clearance K220032 for iStent infinite Trabecular Micro-Bypass System, Model iS3, Substantially Equivalent on 2022-08-02. Applicant: Glaukos Corporation. Device class: 2.

Clearance details

Applicant: Glaukos Corporation
Product code: Code KYF
Device class: Class 2
Regulation: 21 CFR 886.3920
Advisory panel: Ophthalmic
Date received: 2022-01-05
Decision date: 2022-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KYF

product code KYF

Injury: 1,543
Malfunction: 646
Total: 2,189

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.