510(k) Report

FDA applicant

Essilor Of America, Inc.

Dallas, TX1 decision2025–20250 recalls

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, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

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

2025: 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Essilor Of America, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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Other applicant names beginning “Essilor”

FDA records each applicant name separately; these may or may not be the same firm.