BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Electrosurgical, Radio Frequency, Refractive Correction

    PMA: P010018 · Supplement: S004 · Decision Jul 31, 2003
    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
    S004
    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
    July 31, 2003
    Date Received
    July 16, 2003
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE SUB-ASSEMBLY OF THE RCS-300 CONSOLE. THE MANUFACTURING FACILITY IS LOCATED AT REFRACTEC, INC., IRVINE, CALIFORNIA.

    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