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510(k) Data Aggregation

    K Number
    K252845

    Validate with FDA (Live)

    Device Name
    Venus Nova (FP-2001)
    Manufacturer
    Venus Concept Inc.
    Date Cleared
    2025-11-06

    (59 days)

    Product Code
    GEI,NGX,PBX
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K220592,K191528
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Venus Nova device is intended for the treatment of the following medical conditions using the 4D Body (MP2) applicator for delivery of RF energy combined with massage and magnetic field pulses:

    • Relief of minor muscle aches and pain, relief of muscle spasm
    • Temporary improvement of local blood circulation
    • Temporary reduction in the appearance of cellulite

    When used with the Octipolar (LB1) or Diamondpolar (LF1) applicators, the Venus Nova device is intended for use in dermatologic and general surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.

    In addition, the Venus Nova device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles.

    The Venus Nova device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

    The Venus Nova device using the FlexMAX applicators is intended to be operated by a trained professional.

    Device Description

    The Venus Nova device is a computerized device comprised of a console (main unit), one (1) 4D Body applicator containing RF, PEMF and Vacuum, one (1) Octipolar applicator for large anatomical areas containing RF and PEMF, one (1) Diamondpolar applicators for smaller anatomical areas containing RF and PEMF and four (4) FlexMAX applicators containing Electrical Muscle Stimulation (EMS). The device delivers bipolar RF and biphasic electrical energies, vacuum pressure, and pulsed electromagnetic fields (PEMF) to the skin and the underlying tissues of the treatment area. The device provides individual adjustment of EMS intensity level, and RF power, in addition to vacuum levels, for each patient.

    The console of the Venus Nova device contains a power supply unit, RF and EMS controllers, (power modules, on main board), a suction module (vacuum), a controller unit (on main board), a touch-screen user interface and display panel.

    The applicators are connected to the console via cables. The RF applicators are comprised of various combinations of RF electrodes, magnetic coils, and vacuum conduits. The EMS applicators are comprised of two electrodes each and a light indicator.

    AI/ML Overview

    N/A

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