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510(k) Data Aggregation

    K Number
    K252215
    Device Name
    InbellaMAX System
    Manufacturer
    Inbella Medical Ltd.
    Date Cleared
    2025-07-25

    (10 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inbella Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250200
    Device Name
    InbellaBody System
    Manufacturer
    Inbella Medical Ltd.
    Date Cleared
    2025-02-11

    (19 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inbella Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InBellaBody System with BellaTform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions. The BellaTform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The BellaTform Applicator in EMS mode is intended for: - Relaxation of muscle spasms - · Prevention or retardation of disuse atrophy - · Increasing local blood circulation - · Muscle re-education - · Maintaining or increasing range of motion - · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis The BellaTform Applicator in TENS mode is intended for: - · Symptomatic relief and management of chronic, intractable pain - · Post-surgical acute pain - · Post-trauma acute pain Additionally the BellaTform Applicator in sequential RF/EMS mode is intended for: - · Non-invasive lipolysis (breakdown of fat) of the abdomen. - · Reduction in circumference of the abdomen
    Device Description
    The InBellaBody System with BellaTform Applicator is deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The InBellaBody System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The InBellaBody System System includes the following components: - LCD display touch screen, - Audio loudspeaker, - 48V AC/DC power supply, - . Real time controller, distributor card and 2 RF generators, - Fans The System operates while connected to the BellaTform Applicator.
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    K Number
    K243737
    Device Name
    Inbella RF System
    Manufacturer
    Inbella Medical Ltd.
    Date Cleared
    2025-01-03

    (30 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inbella Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Inbella RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.
    Device Description
    The Inbella RF System is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The Inbella RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating. The Inbella RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the handpieces are available, all comprised of a disposable, single use plastic handle with active internal electrodes. A subset of handpieces have both internal (active) and external (return) electrodes.
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