510(k) Report

FDA applicant

Onufryk Low Vision Ent.

Fairport, NY1 decision1990–19900 recalls

FDA records 1 decision for Onufryk Low Vision Ent. (Fairport, NY) in 1990: 1 510(k) clearance. 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, last Nov 3, 2026

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

How often FDA has decided Onufryk Low Vision Ent.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Onufryk Low Vision Ent. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Onufryk Low Vision Ent. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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