FDA applicant

Opto Vision, Inc.

Chicago, IL2 decisions1988–19890 recalls

FDA records 2 decisions for Opto Vision, Inc. (Chicago, IL) from 1988 to 1989: 2 510(k) clearances. Most are in product codes FEI (Instrument, Special Lens, For Endoscope) and FFS (Image, Illumination, Fiberoptic, For Endoscope). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Opto Vision, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Opto Vision, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Opto Vision, 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

Other applicant names beginning “Opto”

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

Opto Global, Inc. 1 Opto Eletronica S/A 1 Opto Electronica SA 1

Opto Vision, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Opto”