BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    CryoTreQ

    K Number: K202038 · Decision Dec 30, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    160

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    Basic Information

    Device Name
    CryoTreQ
    K Number
    K202038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4170
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VitreQ BV
    Date Received
    July 23, 2020
    Decision Date
    December 30, 2020
    Product Code
    HPS
    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
    HPS Unit, Cryophthalmic

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