BEUDAMED
    Product Code: LYI FDA class 3

    Stimulator, Subcortical, Implanted For Epilepsy

    Unknown

    The Subcortical Implanted Stimulator for Epilepsy (product code LYI) is a neurostimulation device surgically implanted in subcortical brain regions to deliver targeted electrical stimulation intended to control or reduce seizure activity in patients with refractory epilepsy. It is classified as a Class 3 device requiring Premarket Approval (PMA) and is flagged as an implant, reflecting the high risk of deep brain stimulation. The device has no formal regulation number or medical specialty designation and is reviewed under the Neurology (NE) panel. It is not life-sustaining.

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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
    LYI
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    NE
    Submission Type
    3

    Device Characteristics

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