FDA applicant

Topcon Medical Systems, Inc.

North Reading, MA11 decisions2003–20180 recalls

FDA records 11 decisions for Topcon Medical Systems, Inc. (North Reading, MA) from 2003 to 2018: 11 510(k) clearances. Most are in product codes NFJ (System, Image Management, Ophthalmic) and OBO (Tomography, Optical Coherence). Its devices cite 16 predicates, 4 of them its own earlier devices. 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 Topcon Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007high 4 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Topcon Medical Systems, 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 “Topcon”

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

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

Topcon Medical Systems, Inc.

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”