BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Photodynamic Therapy

    PMA: P050026 · Supplement: S001 · Decision Sep 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Laser, Photodynamic Therapy
    Trade Name
    QCELLUS LASER
    PMA Number
    P050026
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    MVF
    Generic Name
    SYSTEM, LASER, PHOTODYNAMIC THERAPY
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 26, 2013
    Date Received
    November 19, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) CHANGE IN THE NAME OF THE DEVICE FROM ACTIVIS LASER TO QCELLUS LASER; 2) CHANGE IN THE LASER DESIGN TO COMBINE THE LASER MODULE AND SLIT LAMP ADAPTER INTO A SINGLE UNIT TO BE MOUNTED DIRECTLY ON THE TONOMETER POST OF A HAAG-STREIT 900 BM/BQ SLIT LAMP OR EQUIVALENT; AND 3) CHANGE MANUFACTURING SITE FOR THE QCELLUS LASER TO QLT, INC., VANCOUVER, BC, CANADA.

    Classifications

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

    Product Code Device Name
    MVF System, Laser, Photodynamic Therapy