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510(k) Data Aggregation

    K Number
    K221151
    Device Name
    Beauty LED Mask, Model: KFB265
    Manufacturer
    Hunan Guangye Biotechnology Co., Ltd.
    Date Cleared
    2022-07-19

    (90 days)

    Product Code
    OHS,OLP
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K190443,K183671
    Why did this record match?
    Device Name :

    Beauty LED Mask, Model: KFB265

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

    The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne.

    Device Description

    The Beauty LED Mask adopts light emitting diodes (LED) in the red (637nm ± 5nm) + infrared (854nm ± 5nm) and blue (465 ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect. The Beauty LED Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). Power adapter is provided to charge the battery contained in the controller. To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, Beauty LED Mask has incorporated protective eye-shield which blocks light energy from LEDs.

    AI/ML Overview

    The provided document is a 510(k) summary for the Beauty LED Mask, Model: KFB265. It outlines the device's characteristics and its substantial equivalence to a predicate device, but it does not contain information about clinical studies or specific acceptance criteria and performance data related to its effectiveness in treating wrinkles and acne.

    The document primarily focuses on:

    • Regulatory classification and product codes.
    • Comparison of technological characteristics with predicate devices (e.g., light source, wavelength, power supply, dimensions).
    • Compliance with non-clinical standards, such as electrical safety (IEC 60601 series, IEC 62133-2), photobiological safety (IEC 62471), and biocompatibility (ISO 10993 series).
    • Software verification and validation.

    Therefore, I cannot provide the requested information regarding:

    • A table of acceptance criteria and reported device performance for clinical outcomes.
    • Sample size and data provenance for a test set.
    • Number and qualifications of experts for ground truth establishment.
    • Adjudication method for the test set.
    • Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Standalone algorithm performance.
    • Type of ground truth used (clinical outcomes, pathology, etc.).
    • Sample size and ground truth establishment for a training set.

    The document states that "Non-clinical testings have been conducted to verify that the Beauty LED Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device." This indicates that the 510(k) clearance was based on demonstrating equivalence in non-clinical technical characteristics and safety, rather than requiring new clinical performance data for effectiveness.

    In summary, the provided text describes a regulatory submission based on substantial equivalence to a predicate device through non-clinical testing, not a study proving clinical effectiveness against specific acceptance criteria.

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