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510(k) Data Aggregation

    K Number
    K230841
    Device Name
    NailLift
    Manufacturer
    Date Cleared
    2024-01-22

    (300 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MQZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NailLift is an ingrown toenail corrector that corrects nail curvature by lifting the curved toenails into a more natural shape upon application. The correction of nail curvature results in decreased pain.
    Device Description
    The NailLift is a device for correcting the shape for painful and/or deformed nails without surgery. The NailLift device utilizes Nitinol alloy wires to lift the outer edges of the ingrown or deformed nail. The device uses steel clips to attach the wire form to the nail.
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    K Number
    K162525
    Device Name
    Oniko nail brace
    Date Cleared
    2018-04-25

    (593 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MQZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To correct the shape of overcurved and/or painful nails without operation. To loosen and to give shape to thickened nails, overcurved nails and pincer nails without operation.
    Device Description
    Oniko nail brace is a device for correcting the shape for painful and/or overcurved nails without the use of any operation or anesthesia. Oniko nail brace is composed of metal hooks and silicone bands. The metal hooks grasp the nail sides open to correct the shape or painful and/or overcurved nails.
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    K Number
    K960843
    Device Name
    STOP-N-GROW
    Date Cleared
    1996-08-12

    (165 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MQZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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