EXPRESS MINI GLAUCOMA SHUNT— 510(k) K030350

Substantially Equivalent

Optonol, Ltd.

FDA 510(k) clearance K030350 for EXPRESS MINI GLAUCOMA SHUNT, Substantially Equivalent on 2003-03-13. Applicant: Optonol, Ltd..

Clearance details

Applicant: Optonol, Ltd.
Product code: Code KYF
Advisory panel: Ophthalmic
Date received: 2003-02-03
Decision date: 2003-03-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Duluth, GA, US

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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.