FDA applicant

Topcon Healthcare Solutions

Oakland, NJ2 decisions2020–20230 recalls

FDA records 2 decisions for Topcon Healthcare Solutions (Oakland, NJ) from 2020 to 2023: 2 510(k) clearances. All are in product code NFJ (System, Image Management, Ophthalmic). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Topcon Healthcare Solutions, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

How often FDA has decided Topcon Healthcare Solutions’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Topcon Healthcare Solutions by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Topcon Healthcare Solutions’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 “Topcon”

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

Topcon Corporation 23 Topcon Medical Systems, Inc. 11 Topcon Medical Laser Systems, Inc. 6 Topcon Medical Laser Systems, Inc. (Tmls) 2 Topcon Healthcare Solutions EMEA Oy 2 Topcon Instrument Corporation of America 1

Topcon Healthcare Solutions

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Topcon”