FDA applicant

Topcon Medical Laser Systems, Inc.

Santa Clara, CA6 decisions2005–20181 recall

FDA records 6 decisions for Topcon Medical Laser Systems, Inc. (Santa Clara, CA) from 2005 to 2018: 6 510(k) clearances. Most are in product codes HQF (Laser, Ophthalmic) and GEX (Powered Laser Surgical Instrument). Its devices cite 15 predicates, 4 of them its own earlier devices. 1 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 Laser Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Topcon Medical Laser 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 Systems, Inc. 11 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 Laser 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?

What has been recalled?

Other applicant names beginning “Topcon”