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

    VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System

    K Number: K210300 · Decision Apr 1, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    57

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    Basic Information

    Device Name
    VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
    K Number
    K210300
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vuesonic, LLC
    Date Received
    February 3, 2021
    Decision Date
    April 1, 2021
    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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