ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED)— 510(k) K132714

Substantially Equivalent

Vision Science Co., Ltd.

FDA 510(k) clearance K132714 for ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED), Substantially Equivalent on 2014-03-05. Applicant: Vision Science Co., Ltd..

Clearance details

Applicant: Vision Science Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2013-08-30
Decision date: 2014-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, 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.