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

    PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS

    K Number: K974408 · Decision Apr 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    3
    Review Days
    143

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    Basic Information

    Device Name
    PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS
    K Number
    K974408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biocompatibles Eyewear, Inc.
    Date Received
    November 24, 1997
    Decision Date
    April 16, 1998
    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 Biocompatibles Eyewear, Inc.

    K Number Device Name
    K980218 METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
    K970095 PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS