IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS— 510(k) K974837
Substantially EquivalentIgel Vision Care Pte , Ltd.
FDA 510(k) clearance K974837 for IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS, Substantially Equivalent on 1998-07-06. Applicant: Igel Vision Care Pte , Ltd..
Clearance details
- Applicant
- Igel Vision Care Pte , Ltd.
- Product code
- Code LPL
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Adverse events under product code LPL
product code LPL- Injury
- 988
- Other
- 4
- Total
- 992
Source: openFDA MAUDE database, through . 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.