OPTIMED GLAUCOMA PRESSURE REGULATOR— 510(k) K903462

Substantially Equivalent

Optimed, Inc.

FDA 510(k) clearance K903462 for OPTIMED GLAUCOMA PRESSURE REGULATOR, Substantially Equivalent on 1990-10-16. Applicant: Optimed, Inc..

Clearance details

Applicant: Optimed, Inc.
Product code: Code KYF
Advisory panel: Ophthalmic
Date received: 1990-08-01
Decision date: 1990-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, 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.