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

    AUTOLENS CLEANING AND DISINFECTING UNIT

    K Number: K021699 · Decision Dec 16, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    208

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    Basic Information

    Device Name
    AUTOLENS CLEANING AND DISINFECTING UNIT
    K Number
    K021699
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Autolens, Inc.
    Date Received
    May 22, 2002
    Decision Date
    December 16, 2002
    Product Code
    LYL
    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
    LYL Accessories, Solution, Ultrasonic Cleaners For Lenses

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