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510(k) Data Aggregation

    K Number
    K221466
    Device Name
    IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
    Manufacturer
    Shenzhen Century Dongyuan Technology Co Ltd.
    Date Cleared
    2022-08-12

    (85 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K212897
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IPL Hair Removal Device (Model : AI01, AI06, AI08, AI16, AI17) is intended for the removal of unwanted body hair.

    Device Description

    IPL Hair Removal Device, models: Al01, Al06, Al08, Al16, Al17 are hand-held overthe-counter devices for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). The device is powered by an external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon arc flashlamp, a skin sensor to detect appropriate skin contact, and a skin color detection system to detect the skin color. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The skin color detection system detects whether a skin tone is suitable for treatment. If the skin tone is not in the range suitable for treatment, the device is designed to not emit the treatment light pulses. The light pulses are selectively absorbed by the hair follicles, which results in the hair follicles being temporarily heated. This results in a reduction of hair growth from the treated hair follicles.

    AI/ML Overview

    This document is a 510(k) summary for an IPL Hair Removal Device. The standard details for describing acceptance criteria and clinical study results typical of an AI/ML medical device submission are not available in this document because:

    1. It is not an AI/ML medical device. The device is an Intense Pulsed Light (IPL) hair removal device, which is a physical device rather than an AI/ML algorithm.
    2. It is not a clinical study report. This document is a premarket notification (510(k) summary) whose purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not to report a comprehensive clinical trial.
    3. It explicitly states "There was no clinical testing performed." This immediately negates the possibility of providing information on acceptance criteria based on clinical performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance.

    Therefore, the requested information elements cannot be extracted from the provided text for the following reasons:

    1. A table of acceptance criteria and the reported device performance:
    * No clinical acceptance criteria are provided because no clinical testing was performed. The "performance" section refers to non-clinical testing against recognized standards (e.g., electrical safety, EMC, biocompatibility), not clinical efficacy metrics.

    2. Sample size used for the test set and the data provenance:
    * Not applicable. No clinical test set.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
    * Not applicable. No clinical test set or ground truth establishment relevant to AI performance.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
    * Not applicable.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
    * Not applicable. This is not an AI-assisted device, and no MRMC study was performed.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
    * Not applicable. There is no AI algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
    * Not applicable. No clinical ground truth was established for performance evaluation.

    8. The sample size for the training set:
    * Not applicable. This is not an AI/ML device, so there is no training set.

    9. How the ground truth for the training set was established:
    * Not applicable.

    Summary of available information related to performance/testing:

    The document focuses on non-clinical testing to ensure safety and essential performance of the physical device and its electrical/biocompatibility aspects.

    • Non-Clinical Tests Performed: The device underwent testing to the following standards:
      • ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance)
      • IEC 60601-1-2: 2014 (Electromagnetic Disturbances)
      • IEC 60601-1-11: 2015 (Medical Electrical Equipment for home healthcare environment)
      • ISO 60601-2-57: 2011 (Basic safety and essential performance of non-laser light source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)
      • IEC 62471: 2006 (Photobiological safety of lamps and lamp systems)
      • ISO 10993-5:2009 (Biological evaluation of medical devices - Tests for in vitro cytotoxicity)
      • ISO 10993-10:2010 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)
      • IEC 62304:2006+A1:2015 (Medical device software - Software life cycle processes)
    • Results: All listed non-clinical tests passed.
    • Safety Features: The device includes a skin sensor for contact detection and a skin color detection system to prevent light emission if skin tone is unsuitable.

    The purpose of this 510(k) was to demonstrate substantial equivalence, relying on non-clinical engineering and safety standards, rather than clinical performance data.

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