BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    CureSight-CS100

    K Number: K221375 · Decision Sep 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    140

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    Basic Information

    Device Name
    CureSight-CS100
    K Number
    K221375
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5500
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novasight , Ltd.
    Date Received
    May 12, 2022
    Decision Date
    September 29, 2022
    Product Code
    QQU
    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
    QQU Digital Therapy Device For Amblyopia

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