59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS— 510(k) K040303

Substantially Equivalent

Hydrogel Vision Corporation

FDA 510(k) clearance K040303 for 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS, Substantially Equivalent on 2005-02-02. Applicant: Hydrogel Vision Corporation.

Clearance details

Applicant: Hydrogel Vision Corporation
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2004-02-09
Decision date: 2005-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, 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.