BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Photodynamic Therapy

    PMA: P050026 · Decision Apr 4, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Laser, Photodynamic Therapy
    Trade Name
    QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS
    PMA Number
    P050026
    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
    April 4, 2006
    Date Received
    July 14, 2005
    Expedited Review
    N
    Docket Number
    06M-0162

    Advisory Committee Statement

    APPROVAL FOR THE QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS. THE DEVICE IS INDICATED FOR THE PHOTOACTIVATION OF THE LIGHT ACTIVATED DRUG VISUDYNE (VERTEPORFIN FOR INJECTION) IN PHOTODYNAMIC THERAPY FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO AGE-RELATED MACULAR DEGENERATION, PATHOLOGIC MYOPIA, OR PRESUMED OCULAR HYSTOPLASMOSIS.

    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