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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    System, Laser, Photodynamic Therapy

    PMA: P940012 · Decision Dec 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Laser, Photodynamic Therapy
    Trade Name
    600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS
    PMA Number
    P940012
    Device Class
    FDA Class 3
    Product Code
    MVF
    Generic Name
    SYSTEM, LASER, PHOTODYNAMIC THERAPY
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    December 27, 1995
    Date Received
    April 13, 1994
    Expedited Review
    N
    Docket Number
    97M-0204

    Advisory Committee Statement

    APPROVAL FOR THE 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG (OPERATING AT 532 NM) SURGICAL LASERS

    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