CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES— 510(k) K083216

Substantially Equivalent

Ciba Vision Corporation

FDA 510(k) clearance K083216 for CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, Substantially Equivalent on 2009-04-14. Applicant: Ciba Vision Corporation.

Clearance details

Applicant: Ciba Vision Corporation
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2008-10-31
Decision date: 2009-04-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Duluth, GA, 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.