BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RIGID GAS PERMEABLE CONTACT LENS

    K Number: K002025 · Decision Oct 31, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    5
    Review Days
    120

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    Basic Information

    Device Name
    RIGID GAS PERMEABLE CONTACT LENS
    K Number
    K002025
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Polymer Technology
    Date Received
    July 3, 2000
    Decision Date
    October 31, 2000
    Product Code
    HQD
    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
    HQD Lens, Contact (Other Material) - Daily

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    Other Clearances by Polymer Technology

    K Number Device Name
    K003932 BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY
    K003933 BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
    K001960 RIGID GAS PERMEABLE CONTACT LENS
    K000795 RIGID GAS PERMEABLE CONTACT LENS