BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Electrosurgical, Radio Frequency, Refractive Correction

    PMA: P010018 · Supplement: S009 · Decision Apr 6, 2006
    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
    PMA Number
    P010018
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    MWD
    Generic Name
    Electrosurgical, radio frequency, refractive correction
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 6, 2006
    Date Received
    January 9, 2006
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR UPDATING THE LABELING WITH THE 24 MONTH CLINICAL STUDY RESULTS FOR CK TREATMENT TO IMPROVE NEAR VISION IN THE EMMETROPIC AND HYPEROPIC PRESBYOPES.

    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