FDA applicant
Igel Vision Care Pte, Ltd.
FDA records 4 decisions for Igel Vision Care Pte, Ltd. (Tracy, CA) from 1998 to 2002: 4 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Igel Vision Care Pte, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Igel Vision Care Pte, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Igel Vision Care Pte, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report