MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)— 510(k) K051477

Substantially Equivalent

Mi Gwang Contact Lens Co., Ltd.

FDA 510(k) clearance K051477 for MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC), Substantially Equivalent on 2006-03-10. Applicant: Mi Gwang Contact Lens Co., Ltd..

Clearance details

Applicant: Mi Gwang Contact Lens Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2005-06-03
Decision date: 2006-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Junction, 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.