OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION— 510(k) K002589

Substantially Equivalent

Alcon Universal, Ltd.

FDA 510(k) clearance K002589 for OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION, Substantially Equivalent on 2000-10-23. Applicant: Alcon Universal, Ltd..

Clearance details

Applicant: Alcon Universal, Ltd.
Product code: Code LPN
Advisory panel: Ophthalmic
Date received: 2000-08-21
Decision date: 2000-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

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Adverse events under product code LPN

product code LPN

Injury: 333
Other: 8
Total: 341

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.