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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    System, Non-Coherent Light, Photodynamic Therapy

    PMA: P010061 · Decision Jul 28, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Non-Coherent Light, Photodynamic Therapy
    Trade Name
    CURELIGHT BROADBAND (MODEL CURELIGHT 01)
    PMA Number
    P010061
    Device Class
    FDA Class 3
    Product Code
    MYH
    Generic Name
    System, non-coherent light, photodynamic therapy
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    July 28, 2004
    Date Received
    September 27, 2001
    Expedited Review
    N
    Docket Number
    04M-0345

    Advisory Committee Statement

    APPROVAL FOR THE CURELIGHT BROADBAND (MODEL CURELIGHT 01). THE DEVICE IS INDICATED FOR USE IN COMBINATION WITH TRADENAME CREAM FOR TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF THE FACE AND SCALP IN IMMUNOCOMPETENT PATIENTS WHEN USED IN CONJUNCTION WITH LESION PREPARATION (DEBRIDEMENT USING A SHARP DERMAL CURETTE) IN THE PHYSICIAN'S OFFICE WHEN OTHER THERAPIES ARE UNACCEPTABLE OR CONSIDERED MEDICALLY LESS APPROPRIATE.

    Classifications

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

    Product Code Device Name
    MYH System, Non-Coherent Light, Photodynamic Therapy