BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    System, Laser, Photodynamic Therapy

    PMA: P050021 · Decision Dec 20, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Laser, Photodynamic Therapy
    Trade Name
    CERALAS I LASER
    PMA Number
    P050021
    Device Class
    FDA Class 3
    Product Code
    MVF
    Generic Name
    SYSTEM, LASER, PHOTODYNAMIC THERAPY
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    December 20, 2005
    Date Received
    June 9, 2005
    Expedited Review
    N
    Docket Number
    06M-0161

    Advisory Committee Statement

    APPROVAL FOR THE CERALAS I LASER SYSTEM AND CERALINK SLIT LAMP ADAPTER. 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 HISTOPLASMOSIS.

    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