BEUDAMED
    Product Code: MVF FDA class 3

    System, Laser, Photodynamic Therapy

    Unknown

    A Photodynamic Therapy Laser System is a device that emits laser light at specific wavelengths to activate photosensitizing agents accumulated in target tissues, generating cytotoxic reactive oxygen species to destroy cancerous or abnormal cells as part of photodynamic therapy (PDT). It is classified as FDA Class 3, requiring PMA approval, with product code MVF. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MVF
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    SU
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.