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

    ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING

    K Number: K964222 · Decision Dec 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    21
    Applicant Total
    14
    Review Days
    59

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    Basic Information

    Device Name
    ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
    K Number
    K964222
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paladin Medical, Inc.
    Date Received
    October 22, 1996
    Decision Date
    December 20, 1996
    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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