FDA applicant

Topcon Instrument Corporation of America

Paramus, NJ1 decision1987–19870 recalls

FDA records 1 decision for Topcon Instrument Corporation of America (Paramus, NJ) in 1987: 1 510(k) clearance. All are in product code HKX (Tonometer, Ac-Powered). 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 Instrument Corporation of America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Topcon Instrument Corporation of America since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Topcon Instrument Corporation of America by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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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 Healthcare Solutions 2 Topcon Medical Laser Systems, Inc. (Tmls) 2 Topcon Healthcare Solutions EMEA Oy 2

Topcon Instrument Corporation of America

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Topcon”