IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS— 510(k) K984523

Substantially Equivalent

Igel Vision Care Pte , Ltd.

FDA 510(k) clearance K984523 for IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS, Substantially Equivalent on 1999-02-16. Applicant: Igel Vision Care Pte , Ltd..

Clearance details

Applicant: Igel Vision Care Pte , Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1998-12-21
Decision date: 1999-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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.