BEUDAMED
    Product Code: LLW FDA class 2 21 CFR 884.4550

    Laser, Neodymium:Yag For Gynecologic Use

    Obstetrics/Gynecology

    Laser, Neodymium:YAG for Gynecologic Use is an Nd:YAG laser system used in gynecological surgical procedures, such as treatment of endometriosis, ablation of cervical or vaginal lesions, and other gynecologic tissue interventions requiring precise thermal energy delivery. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LLW, regulated under 21 CFR 884.4550, within the Obstetrics/Gynecology medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    LLW
    Device Class
    FDA class 2
    Regulation Number
    884.4550
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K850437 DISPOSABLE LARYNGOSCOPE