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

    FLEXLENS

    K Number: K961943 · Decision Oct 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    4
    Review Days
    134

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    Basic Information

    Device Name
    FLEXLENS
    K Number
    K961943
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Flexlens, Inc.
    Date Received
    May 20, 1996
    Decision Date
    October 1, 1996
    Product Code
    LPL
    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
    LPL Lenses, Soft Contact, Daily Wear

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    Other Clearances by Flexlens, Inc.

    K Number Device Name
    K970312 CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)
    K962000 FLEXLENS(METHAFILCON A)
    K950294 FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS