CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS— 510(k) K082393

Substantially Equivalent

Unilens Corp., USA

FDA 510(k) clearance K082393 for CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS, Substantially Equivalent on 2008-09-11. Applicant: Unilens Corp., USA.

Clearance details

Applicant: Unilens Corp., USA
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2008-08-19
Decision date: 2008-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Largo, 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.