BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Laser, Ophthalmic

    PMA: P990078 · Supplement: S004 · Decision Mar 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    62

    Basic Information

    Device Name
    Laser, Ophthalmic
    Trade Name
    SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)
    PMA Number
    P990078
    Supplement Number
    S004
    Device Class
    FDA Class 2
    Product Code
    HQF
    Generic Name
    Laser, ophthalmic
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 16, 2001
    Date Received
    December 26, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A SOFTWARE MODIFICATION TO THE EYE TRACKER.

    Classifications

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

    Product Code Device Name
    HQF Laser, Ophthalmic