Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)— 510(k) K143431

Substantially Equivalent

I-Codi Co., Ltd.

FDA 510(k) clearance K143431 for Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted), Substantially Equivalent on 2015-02-20. Applicant: I-Codi Co., Ltd..

Clearance details

Applicant: I-Codi Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2014-12-01
Decision date: 2015-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buk-Gu, KR

Download summary PDF View on FDA.gov ↗

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.