BEUDAMED
    Product Code: LOG FDA class 3

    Catheter, Balloon For Retinal Reattachment

    Unknown

    Catheter, Balloon for Retinal Reattachment is a balloon catheter used in ophthalmic surgery to mechanically support or tamponade the detached retina from within the eye, allowing reattachment of the retina to the underlying retinal pigment epithelium as part of surgical management of retinal detachment. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The product code is LOG; no regulation number has been assigned, and the review panel is Ophthalmology. No special flags apply to this device.

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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
    LOG
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OP
    Submission Type
    2

    Device Characteristics

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