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

    SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS

    K Number: K052675 · Decision Nov 30, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    2
    Review Days
    64

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    Basic Information

    Device Name
    SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS
    K Number
    K052675
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synergeyes
    Date Received
    September 27, 2005
    Decision Date
    November 30, 2005
    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 Synergeyes

    K Number Device Name
    K051035 SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS