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

    OPTI-LENS(TM) CONTACT LENS CASE

    K Number: K915082 · Decision Jan 13, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    81
    Applicant Total
    10
    Review Days
    62

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    Basic Information

    Device Name
    OPTI-LENS(TM) CONTACT LENS CASE
    K Number
    K915082
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ryder Intl. Corp.
    Date Received
    November 12, 1991
    Decision Date
    January 13, 1992
    Product Code
    LRX
    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
    LRX Case, Contact Lens

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