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510(k) Data Aggregation

    K Number
    K230549
    Device Name
    IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG
    Manufacturer
    Shenzhen Xiazhifeng Electronic Co., Ltd.
    Date Cleared
    2023-04-25

    (56 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K220669,K220248
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IPL Hair Removal Device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.

    Device Description

    The IPL Hair Removal Device is a personal, light-based, hair reduction device. The device provides hair reduction using IPL technology. Of which, the Device includes FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AG, FY-B509AG, FY-B509BL, FY-B509BG sixteen models. All have adopted the same structure design, consisting of IPL Hair Removal Device main unit and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from power adapter via an external power. The difference of all models is mainly appearance, cooling function and enclosure color, letter A in the model name means with skin cooling function, letter B means without skin cooling function, letter L means the enclosure color is light green, letter G is deep green, which do not affect the intended use.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for an IPL Hair Removal Device, primarily focusing on demonstrating its substantial equivalence to previously cleared predicate devices rather than providing a detailed study proving its performance against acceptance criteria.

    Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment are not present in this document. The document primarily focuses on demonstrating conformance to established safety and electrical standards and comparing specifications with predicate devices.

    However, I can extract what is available:

    1. A table of acceptance criteria and the reported device performance

    The document does not explicitly list "acceptance criteria" for clinical performance. Instead, it refers to equivalence with predicate devices and compliance with various safety and performance standards. The reported performance is implicitly through meeting these standards and having similar specifications to the predicate devices.

    Acceptance Criteria (Inferred from regulatory compliance and predicate comparison)Reported Device Performance
    Biocompatibility: No adverse biological reactions from body-contacting componentsPassed ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (skin irritation).
    Electrical Safety & EMC: Compliance with relevant electrical safety and electromagnetic compatibility standardsPassed IEC 60601-1-2, ANSI AAMI ES60601-1, IEC 60601-1-11, IEC 60601-2-83.
    Eye Safety: Compliance with photobiological safety standardsPassed IEC 62471.
    Software Verification & Validation: Software meets requirements and hazards are mitigated.System validation testing demonstrated all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
    Usability: Compliance with human factors and usability engineering guidance.Evaluated and verified according to "Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016".
    Product Output Energy Density: Product delivers energy density within specification.Tested and verified according to product specification; complied with requirement.
    Product Pulse Duration: Product delivers pulse duration within specification.Tested and verified according to product specification; complied with requirement.
    Indications for Use: Over-the-counter device, intended for removal of unwanted body and/or facial hair.Matches predicate devices and is stated as an intended use.
    Applicable Skin Types: Fitzpatrick Skin Phototypes I-V.Matches predicate devices and is stated.
    Treatment Area: Small areas such as underarm, bikini line; large areas such as legs, arms.Similar to predicate devices.
    Light Source: Intense Pulsed Light.Same as predicate devices.
    Energy Medium: Xenon Flashlamp (or similar).Similar to predicate devices (Xenon Quartz Tube, Xenon Arc Flashlamp).
    Wavelength Range: 510-1100nm.Similar to predicate devices (470-1100nm, 530-1100nm).
    Energy Density: 1.1 ~ 3.0 J/cm².Similar to predicate devices (1.3-2.49 J/cm², 2.0~4.3 J/cm²).
    Output Energy: 4.0 J~10.8 J.Similar to predicate devices (various levels from 3.92J-7.48J and 7.8-15.39 J).
    Spot Size: 3.6 cm².Similar to predicate devices (3 cm², 3.5 cm², 3.9 cm²).

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    The document does not provide details about a clinical test set or sample size for demonstrating hair removal efficacy. The performance data listed (Biocompatibility, Electrical Safety, Eye Safety, Software, Usability, Output energy density, Pulse duration) are primarily in-house or third-party laboratory tests, not human clinical trials with a "test set" in the sense of patient data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    This information is not available in the provided text, as the document does not describe a clinical study involving a "test set" requiring expert ground truth.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    This information is not available in the provided text.

    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

    This is not applicable to a hair removal device. MRMC studies are typically for medical imaging devices where human readers interpret images, sometimes with AI assistance.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    This concept is not applicable to a physical hair removal device. The device's "performance" is its ability to remove hair, which is a direct physical effect, not an algorithmic interpretation.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    For the technical performance aspects (biocompatibility, electrical safety, etc.), the "ground truth" is defined by the standards themselves and the test results' compliance with these standards. For hair removal efficacy, the document does not describe any specific clinical ground truth or outcomes data. The marketing clearance is based on substantial equivalence to predicate devices, implying similar "hair removal" outcomes without a new clinical study.

    8. The sample size for the training set

    This information is not applicable as this device does not appear to use machine learning in a way that would require a "training set" for an algorithm.

    9. How the ground truth for the training set was established

    This information is not applicable.

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