FDA applicant
Essilor Of America, Inc.
FDA records 1 decision for Essilor Of America, Inc. (Dallas, TX) in 2025: 1 De Novo grant. All are in product code QUR (Prescription Spectacle Lenses To Reduce The…). 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 Essilor Of America, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Essilor Of America, Inc.’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) ReportOther applicant names beginning “Essilor”
FDA records each applicant name separately; these may or may not be the same firm.