BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Electrosurgical, Radio Frequency, Refractive Correction

    PMA: P010018 · Supplement: S001 · Decision Oct 28, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Electrosurgical, Radio Frequency, Refractive Correction
    Trade Name
    VIEWPOINT CK SYSTEM (KERATOPLAST TIP COMPONENT)
    PMA Number
    P010018
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    MWD
    Generic Name
    Electrosurgical, radio frequency, refractive correction
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 28, 2002
    Date Received
    October 21, 2002
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ALTERNATIVE/ EQUIVALENT UV CURABLE ADHESIVE TO BE USED IN THE BONDING PROCESS DURING MANUFACTURE OF THE KERATOPLAST TIP.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MWD Electrosurgical, Radio Frequency, Refractive Correction