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

    BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY

    K Number: K003933 · Decision Feb 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    5
    Applicant Total
    5
    Review Days
    58

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    Basic Information

    Device Name
    BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
    K Number
    K003933
    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
    December 20, 2000
    Decision Date
    February 16, 2001
    Product Code
    MUW
    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
    MUW Lens, Contact (Orthokeratology)

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    Other Clearances by Polymer Technology

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