BEUDAMED
    Product Code: LMH FDA class 3

    Implant, Dermal, For Aesthetic Use

    Unknown

    Implant, Dermal, for Aesthetic Use is a device surgically implanted into the dermis or subcutaneous tissue for cosmetic or aesthetic purposes, such as augmenting soft tissue volume, correcting contour defects, or reducing the appearance of wrinkles, including materials such as silicone gel or other biocompatible substances. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The product code is LMH; no regulation number has been assigned, and the review panel is General/Plastic Surgery. This device is an implant.

    View on FDA
    510(k)s
    0
    FEI Numbers
    33
    Registration Numbers
    33
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

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

    Registration Numbers

    This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.