FDA applicant
Unilens Corp., USA
FDA records 16 decisions for Unilens Corp., USA (Largo, FL) from 1989 to 2014: 14 510(k) clearances and 2 original PMA approvals. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and LPM (Lenses, Soft Contact, Extended Wear). Its devices cite 26 predicates, 11 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Unilens Corporation, USA”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Unilens Corp., USA’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Unilens Corp., USA’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