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510(k) Data Aggregation

    K Number
    K221574
    Device Name
    LUDWIG Electrosurgical Device
    Date Cleared
    2022-10-16

    (137 days)

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

    Aesthetics Biomedical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LUDWIG Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The LUDWIG Electrosurgical System is comprised of the following components: - . The system's main body, which consists of: - Touch-screen control/display panel O - High radio frequency (RF)-generating output component at 0.5, 1 or 2 MHz o - RF Handpiece for transfer of energy to human tissue O - Ultrasound Handpiece for visualization of dermis and epidermis O - Disposable bipolar micro-needle cartridge (electrode) that is inserted into RF o Handpiece and used for coagulation of human tissue - O Power cord The LUDWIG Electrosurgical System generates radiofrequency (RF) energy by means of high RF at .5 MHz, 1MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue.
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