BEUDAMED
    Product Code: LPC FDA class 3

    Device, Angioplasty, Laser, Coronary

    Unknown

    The Coronary Laser Angioplasty Device is used to recanalize blocked or narrowed coronary arteries by delivering laser energy percutaneously to ablate or vaporize atherosclerotic plaque. It is classified as a Class 3 (highest risk) device under FDA regulations, requiring Premarket Approval (PMA) given the serious risks inherent in laser-based coronary intervention. The product code is LPC; no specific regulation number or medical specialty code is listed for this entry, though the review panel is Cardiovascular (CV). No special flags apply to this device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    LPC
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    CV
    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 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.