IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR— 510(k) K021907

Substantially Equivalent

Igel Vision Care Pte , Ltd.

FDA 510(k) clearance K021907 for IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, Substantially Equivalent on 2002-09-04. Applicant: Igel Vision Care Pte , Ltd..

Clearance details

Applicant: Igel Vision Care Pte , Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2002-06-10
Decision date: 2002-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tracy, CA, US

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.