WESTCON HORIZON 49% (HIOXIFILCON B)— 510(k) K080686

Substantially Equivalent

Westcon Contact Lens Co.

FDA 510(k) clearance K080686 for WESTCON HORIZON 49% (HIOXIFILCON B), Substantially Equivalent on 2008-04-22. Applicant: Westcon Contact Lens Co..

Clearance details

Applicant: Westcon Contact Lens Co.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2008-03-11
Decision date: 2008-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Erie, CO, US

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Adverse events under product code LPL

product code LPL

Injury: 988
Other: 4
Total: 992

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.