EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS— 510(k) K012852

Name: FDA 510(k) clearance K012852
Creator: U.S. Food and Drug Administration
Published: 2002-03-26

Substantially Equivalent

Optonol, Ltd.

FDA 510(k) clearance K012852 for EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS, Substantially Equivalent on 2002-03-26. Applicant: Optonol, Ltd.. Device class: 2.

Clearance details

Applicant: Optonol, Ltd.
Product code: Code KYF
Device class: Class 2
Regulation: 21 CFR 886.3920
Advisory panel: Ophthalmic
Date received: 2001-08-24
Decision date: 2002-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, 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.