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    K Number
    K223893
    Device Name
    Infrared Heat (Model: E0221)
    Manufacturer
    Light Tree Ventures Europe B.V.
    Date Cleared
    2023-05-16

    (139 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K171323,K201107
    Why did this record match?
    Device Name :

    Infrared Heat (Model: E0221)

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

    The Infrared Heat (Model: E0221) is intended to emit energy in the red and infrared spectrum for use in the treatment of full face wrinkles.

    Device Description

    The Infrared Heat, model: E0221, is an over-the-counter light emitting diode (LED) device that emits 630nm and 830nm light to treat wrinkles. The device uses three types of LEDs and has two modes to reach those two functions. The user can control the treatment time or automatically shut it off within a set time. The Infrared Heat components include the main unit device (a pad), an adjustable strap, a USB charging cord, goggles and a user manual. The user wears the device in the area which needs to treat, and the device will shut down automatically a 10-minute after finishing treatment.

    AI/ML Overview

    The provided documentation does not describe a study that involves a test set, expert readers, or ground truth establishment in the context of an AI/ML device. The device in question, "Infrared Heat (Model: E0221)," is an LED device intended for the treatment of full face wrinkles. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to previously marketed predicate devices.

    The document explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

    Therefore, the information requested in the prompt (regarding acceptance criteria, test set, expert readers, ground truth, MRMC studies, standalone performance, training set details) is not applicable to the provided document. The evaluation of this device relies on non-clinical tests and comparison to predicate devices, rather than a clinical study involving human judgment of AI outputs.

    The non-clinical tests performed relate to electrical safety, electromagnetic compatibility, photobiological safety, battery safety, biocompatibility, and software/usability testing, all in conformance with specific international standards (e.g., IEC, ISO). The comparison to predicate devices focuses on design principles, intended use, functions, materials, and compliance with standards.

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