BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    TOPCON CORP.

    Reg #: 9614661 · FEI: 1000175127 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    81
    Establishment Types
    1
    Classifications
    18

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    Registration Details

    Registration Name
    TOPCON CORP.
    Registration Number
    9614661
    FEI Number
    1000175127
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    75-1 HASUNUMA-CHO, ITABASHI-KU
    City
    TOKYO
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K170164

    Owner / Operator

    Firm Name
    Topcon Healthcare, Inc.
    Operator Number
    9031569
    Address
    111 Bauer Drive
    City
    Oakland
    State
    NJ
    Postal Code
    07436
    Country
    US

    US Agent

    Business Name
    Topcon Healthcare, Inc.
    Contact Name
    Susan Quick
    Address
    111 Bauer Drive
    City
    Oakland
    State
    NJ
    ZIP
    07436
    Country
    US
    Email
    [email protected]
    Phone
    216 7805532

    Products

    Device Name Product Code
    Projector, Ophthalmic HOS
    Tomography, Optical Coherence OBO
    Camera, Ophthalmic, Ac-Powered HKI
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    System, Image Management, Ophthalmic NFJ
    Pupillometer, Manual HLH
    Microscope, Operating & Accessories, Ac-Powered, Ophthalmic HRM
    Tonometer, Ac-Powered HKX
    Microscope, Specular NQE
    Set, Lens, Trial, Ophthalmic HPC
    Instrument, Measuring, Lens, Ac-Powered HLM
    Chart, Visual Acuity HOX
    Device, Analysis, Anterior Segment MXK
    Instrument, Measuring, Corneal Radius HJB
    Refractor, Manual, Non-Powered, Including Phoropter HKN
    Table, Instrument, Powered, Ophthalmic HRJ
    Frame, Trial, Ophthalmic HPA
    Refractometer, Ophthalmic HKO

    Proprietary Names

    ACP-8 ACP-8R 3D OCT-1 Maestro 3D OCT-1 (Type:Maestro2) NW500 TRC-NW8F SL-D701 SL-D2 SL-D4 SL-D7 SL-3G SL-D8Z SL-1E SL-D4 (Type:LED) IMAGEnet 6 IMAGEnet 7 SL-2G TRC-50DX PD-5 OMS-90 OMS-710 OMS-800 SL-D301 CT-80 TRC-NW8F plus SP-1P 3D OPTICAL COHERENCE TOMOGRAPHY (3D OCT-1(type: Maestro2)) IMAGEnet6 Ophthalmic Data System TLS-AF TLS LM-8; LM-8E; CL-200; EZ-200 CL-300 DRI OCT Triton (plus) DRI OCT Triton SP-3000P SS-3 MC-4S MIRROR CHART MC-5S PC-50S TRC-NW300 IMAGEnet6 TRK-3 OMNIA TRC-NW400 TRC-NW8 OM-4 3D OCT-1000 VT-10 CV-5000 TRC-NW7SF MARK II IMAGEnet 5 CT-800 CT-1P CT-1 TRK-1P TRK-2P CT-800A 3D OCT-1000 MARK II 3D OCT-2000 3D OCT-1(type: Maestro2) AIT-16 TF-3 T-FRAME KR-800S KR-1W KR-800A RM-800 KR-8000PA KR-800PA KR-8900 KR-1 Chronos RM-8900 KR-800 DRI OCT Triton Plus 3D OCT-2000 FA DRI OCT-1 Model Triton Plus 3D OCT-2000 (50k) 3D OCT-2000 FA plus DRI OCT-1 Model Triton DRI OCT Triton2 IMAGEnet R4

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility