Topcon Medical Systems, Inc.: FDA filings under this applicant name

FDA lists 11 510(k) clearances under the applicant name “Topcon Medical Systems, Inc.” (first 2003, latest 2018), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 89 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Topcon Medical Systems, Inc. took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 149 days.

Top product codes

Review panels

• Ophthalmic (11)

Most recent Topcon Medical Systems, Inc. 510(k) clearances

1 earlier clearances. See the full list in Caduvo.

Recalls

3 product recalls in 3 recall events; 1 initiated in the last five years. Most recent: 2024-09-17.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Topcon Medical Systems, Inc. is the lead sponsor of 14 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT03439774: Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer and Topcon SP-1P (Completed, started 2017-05-05)
• NCT03107104: Triton Fundus Autofluorescence and Fluorescein Angiography (Completed, started 2017-03-30)
• NCT03080714: Triton Agreement and Precision Study (Completed, started 2017-03-13)
• NCT03022383: TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus (Completed, started 2017-01)
• NCT02982174: Evaluation of the Signal to Noise Ratio at Various Retinal Layers (Completed, started 2016-12)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Topcon Corporation (23 510(k)s)
• Topcon Medical Laser Systems, Inc. (6 510(k)s)
• Topcon Healthcare Solutions (2 510(k)s)
• Topcon Healthcare Solutions EMEA Oy (2 510(k)s)
• Topcon Medical Laser Systems, Inc. (Tmls) (2 510(k)s)
• Topcon Instrument Corporation of America (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Topcon Medical Systems, Inc.?

FDA lists 11 510(k) clearances under the applicant name “Topcon Medical Systems, Inc.” (first 2003, latest 2018), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Topcon Medical Systems, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Topcon Medical Systems, Inc. is 89 days.

Which FDA product codes appear under Topcon Medical Systems, Inc.?

The most frequent FDA product codes under this applicant name are NFJ (System, Image Management, Ophthalmic, 5); HKI (Camera, Ophthalmic, Ac-Powered, 2); OBO (Tomography, Optical Coherence, 2).

Next steps

• See all 11 Topcon Medical Systems, Inc. clearances with predicates and recalls
• Run predicate analysis for product code NFJ, Topcon Medical Systems, Inc.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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