FDA applicant
Polycore Optical Pte, Ltd.
FDA records 7 decisions for Polycore Optical Pte, Ltd. (Mchenry, IL) from 1979 to 1983: 7 510(k) clearances. All are in product code HQG (Lens, Spectacle, Non-Custom (Prescription)). 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 Polycore Optical Pte, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Polycore Optical Pte, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Polycore Optical 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