BEUDAMED
    Product Code: OEL FDA class 2 21 CFR 878.4810

    Laser, Benign Prostatic Hyperplasia

    General, Plastic Surgery

    The Laser for Benign Prostatic Hyperplasia (product code OEL) is a surgical device that uses laser energy to ablate prostatic tissue for the treatment of symptomatic BPH, reducing urinary obstruction by vaporizing or enucleating excess glandular tissue through the urethra. Various laser modalities such as holmium or photoselective vaporization may be used. This device is FDA Class 2 under regulation 878.4810 in the General, Plastic Surgery specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    OEL
    Device Class
    FDA class 2
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

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

    Definition

    Laser ablation of prostatic tissue for the treatment of benign prostatic hyperplasia