510(k) Report

FDA applicant

Int'L Eye Care, Inc.

Rochester, NY1 decision1986–19860 recalls

FDA records 1 decision for Int'L Eye Care, Inc. (Rochester, NY) in 1986: 1 510(k) clearance. All are in product code HOI (Spectacle, Magnifying). 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 Int'L Eye Care, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Int'L Eye Care, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Int'L Eye Care, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Int'L Eye Care, 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) Report