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510(k) Data Aggregation

    K Number
    K024307
    Device Name
    DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
    Manufacturer
    SYBARITIC, INC.
    Date Cleared
    2003-07-02

    (190 days)

    Product Code
    IMI,ISA
    Regulation Number
    890.5300
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYBARITIC, INC.

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

    Indications for use include the following:
    a. Therapeutic Massager:
    i. Provides temporary relief of minor muscle aches and pains
    ii. Relieves muscle spasms
    iii. Temporarily improves local blood circulation
    iv. Temporarily reduces the appearance of cellulite
    b. Ultrasonic Diathermy :
    i. Relief of pain
    ii. Muscle spasms
    iii. Joint contractures
    iv. NOT for the treatment of malignancies

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies in the context of an AI/algorithm-based device.

    The document is an FDA 510(k) clearance letter for a device called "Dermosonic Non-Invasive Subdermal Therapy System". It describes the device's indications for use and states that it has been found "substantially equivalent" to legally marketed predicate devices.

    Therefore, I cannot fulfill your request as the necessary information is not present in the given text.

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