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510(k) Data Aggregation

    K Number
    K241099
    Device Name
    Plasonic (Plasonic)
    Manufacturer
    Hironic Co., Ltd.
    Date Cleared
    2024-11-08

    (200 days)

    Product Code
    GEI,IMI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K223222,K230472,K161628
    Why did this record match?
    Device Name :

    Plasonic (Plasonic)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PLASONIC with PLAPASS handpiece (Radiofrequency) is intended for the removal and destruction of skin lesions and coagulation of tissue.

    The PLASOINC with SONOPASS handpiece (Ultrasound) is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques.

    Device Description

    The device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, two handpieces, foot switch, LCD touchscreen and power cable.

    The PLASONIC has two systems (two handpieces) :

      1. Radiofrequency (PLAPASS Handpiece) The device is intended for the removal and destruction of skin lesions and coagulation of tissue. The system is intended for use by trained healthcare professionals in a clinical setting to provide controlled radiofrequency therapy through non-invasive procedure.
      1. Ultrasound (SONOPASS Handpiece)

    The device is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques. The device is designed to deliver therapeutic ultrasound waves, promoting tissue relaxation and aiding in the recovery process for improved patient well-being

    AI/ML Overview

    The provided text describes a 510(k) submission for a medical device called "PLASONIC." It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on non-clinical tests.

    Therefore, I cannot provide the requested table or answer questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the given text.

    The text does state the following regarding studies:

    • Non-clinical tests:
      • Compliance with several IEC and ISO standards for electrical safety, electromagnetic compatibility, usability, software lifecycle processes, and risk management (listed in section 7).
      • An ex vivo model study where handpieces were applied to analyze temperature change via thermal imaging, and tissue coagulation length, width, and depth via photography and histological evaluation.
    • Clinical tests: "No clinical test was performed."
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