Medical Device Manufacturer · US , North Reading , MA

Topcon Corporation - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2014

Recent clearances: SLIT LAMP SL-D4 (Type: LED), AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA, 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)

14
Total
14
Cleared
0
Denied

Topcon Corporation has 14 FDA 510(k) cleared ophthalmic devices. Based in North Reading, US.

Latest FDA clearance: Sep 2026. Active since 2014.

Browse the complete list of FDA 510(k) cleared ophthalmic devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Orasi Consulting, Hogan Lovells US LLP and O'Connell Regulatory Consultants, Inc.. 3 devices have linked clinical trials registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Topcon Corporation

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