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

    LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR

    K Number: K963010 · Decision Nov 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    7
    Review Days
    110

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    Basic Information

    Device Name
    LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR
    K Number
    K963010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Permeable Technologies, Inc.
    Date Received
    August 2, 1996
    Decision Date
    November 20, 1996
    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 Permeable Technologies, Inc.

    K Number Device Name
    K963001 LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
    K963011 LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR
    K951893 LIFESTYLE 55 (OCUFILCON D) HYDROPHILIC CONTACT LENS LIFESTYLE FREQUENCY 55 (OCUFILCON D) GHYDROPHILIC CONTACT LENS
    K950283 LIFESTYLE 4-VUE(TM) (POLYMACON) HYDROPHILIC CONTACT LENS
    K945981 LIFESTYLE 55 (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENS
    K942494 LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS