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Topcon Corporation

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories5
Latest Approval2025-11-07
TypeNumberDevice NameCodeDate
510(k) K253039 AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA HKX 2025-11-07 View
510(k) K241081 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System OBO 2024-07-17 View
510(k) K233561 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) OBO 2024-04-10 View
510(k) K232828 IMAGEnet6 Ophthalmic Data System NFJ 2024-03-01 View
510(k) K231222 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) OBO 2023-10-30 View
510(k) K221111 Non-Mydriatic Retinal Camera NW500 HKI 2022-08-29 View
510(k) K173119 DRI OCT Triton OBO 2018-01-19 View
510(k) K171370 IMAGEnet 6 Ophthalmic Data System NFJ 2017-11-01 View
510(k) K170164 3D OCT-1 Maestro OBO 2017-03-03 View
510(k) K161972 Slit Lamp SL-D301 HJO 2016-12-09 View
510(k) K161509 3D OCT-1 Maestro OBO 2016-07-28 View