FDA applicant

Intelon Optics, Inc.

Woburn, MA1 decision2024–20240 recalls

FDA records 1 decision for Intelon Optics, Inc. (Woburn, MA) in 2024: 1 510(k) clearance. All are in product code MXK (Device, Analysis, Anterior Segment). 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 Intelon Optics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Intelon Optics, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intelon Optics, 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

Intelon Optics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?