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510(k) Data Aggregation

    K Number
    K210119
    Device Name
    IPL Hair Removal Device (Model: KCA423)
    Manufacturer
    Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd
    Date Cleared
    2021-05-21

    (122 days)

    Product Code
    ONF
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IPL Hair Removal Device (Model: KCA423) indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for an IPL Hair Removal Device (Model: KCA423). It primarily addresses the regulatory approval process and states the device's indications for use. It does not contain the detailed technical study information, acceptance criteria, or performance data that would be needed to answer your request fully.

    The request asks for information typically found in a clinical study report or a 510(k) summary, which outlines the scientific evidence demonstrating the device meets performance criteria. This document only confirms that the FDA has reviewed the submission and found the device to be substantially equivalent to a predicate device.

    Therefore, I cannot provide the requested information based solely on the provided text. The document does not contain:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set or data provenance.
    3. Number of experts used to establish ground truth or their qualifications.
    4. Adjudication method for the test set.
    5. Information about MRMC comparative effectiveness studies or effect sizes.
    6. Results of a standalone algorithm performance study.
    7. The type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    To obtain this information, you would typically need to refer to the full 510(k) submission, specifically the sections detailing the performance data and clinical studies, which are not included in this FDA clearance letter.

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