IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT— 510(k) K020855

Substantially Equivalent

Igel Vision Care Pte , Ltd.

FDA 510(k) clearance K020855 for IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT, Substantially Equivalent on 2002-06-04. Applicant: Igel Vision Care Pte , Ltd..

Clearance details

Applicant: Igel Vision Care Pte , Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2002-03-15
Decision date: 2002-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tracy, CA, 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.