BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Specular Microscope CEM-530

    K Number: K173980 · Decision Mar 14, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    8
    Same Product Code
    8
    Applicant Total
    20
    Review Days
    75

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Specular Microscope CEM-530
    K Number
    K173980
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nidek Co., Ltd.
    Date Received
    December 29, 2017
    Decision Date
    March 14, 2018
    Product Code
    NQE
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NQE Microscope, Specular

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NQE), ordered by most recent decision date.

    Konan Specular Microscope XVII

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    EM-4000 Specular Microscope

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Specular Microscope CEM- 530

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SP-1PSpecular Microscope

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPECULAR MICROSCOPE CEM-530

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    KONAN SPECULAR MICROSCOPE XIV

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Nidek Co., Ltd.

    K Number Device Name
    K221320 Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
    K203130 Ophthalmic Yag Laser System YC-200
    K192045 Ophthalmic Yag Laser System YC-200
    K190198 Microperimeter MP-3, Microperimeter MP-3 Type S
    K181345 Image Filing Software NAVIS-EX
    K170302 YELLOW LASER PHOTOCOAGULATOR YLC-500
    K163564 SLIT LAMP SL-2000
    K152729 MICROPERIMETER MP-3
    K152603 Green Laser Photocoagulator GYC-500
    K151706 Specular Microscope CEM- 530
    Search all 20 clearances from Nidek Co., Ltd. →