Chrysalis Intelligence · Sponsors · Topcon Corporation

Topcon Corporation

Tokyo, JP · 6 510(k) clearances

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Total clearances
6
2022-08-29 → 2025-11-07
Last 12 months
1
Product codes
4
Most recent
2025-11-07
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OBO Tomography, Optical Coherence Class II Ophthalmic 3 2024-07-17
HKX Tonometer, Ac-Powered Class II Ophthalmic 1 2025-11-07
NFJ System, Image Management, Ophthalmic Class II Radiology 1 2024-03-01
HKI Camera, Ophthalmic, Ac-Powered Class II Ophthalmic 1 2022-08-29
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2025-11-07 K253039 AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA HKX Class II Ophthalmic
2024-07-17 K241081 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System OBO Class II Ophthalmic
2024-04-10 K233561 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) OBO Class II Ophthalmic
2024-03-01 K232828 IMAGEnet6 Ophthalmic Data System NFJ Class II Radiology
2023-10-30 K231222 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) OBO Class II Ophthalmic
2022-08-29 K221111 Non-Mydriatic Retinal Camera NW500 HKI Class II Ophthalmic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence