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510(k) Data Aggregation

    K Number
    K251909
    Manufacturer
    Date Cleared
    2025-09-03

    (75 days)

    Product Code
    Regulation Number
    882.5890
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SX2500 / SX3800 Series devices uses microcurrent electrical energy to stimulate facial tissues for aesthetic purposes.

    Device Description

    The subject devices, SX2500 & SX3800, under the NFO Product Code, uses microcurrent electrical energy to stimulate facial tissues for aesthetic purposes. The SX series uses applied accessories like probes, gloves or pads to deliver low electrical current to stimulation of facial tissues for aesthetic purposes.

    The SX2500 & SX3800 is a powered microcurrent stimulator that uses electrical energy to stimulate facial tissues for aesthetic purposes. The SX2500 & SX3800 is substantially equivalent to the predicate devices compared in its product code class and has the same IFU. The SX2500 & SX3800 delivers signals independently to specific facial area points by way of channel ports via stainless steel probes and applicators substantially equivalent to the predicate device. The probes, gloves and pads referenced are the only patient contacting parts on the device that is substantially equivalent to the predicate device.

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