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510(k) Data Aggregation

    K Number
    K141242
    Device Name
    GLIDE DEVICE
    Manufacturer
    HOME SKINOVATIONS LTD.
    Date Cleared
    2014-10-17

    (156 days)

    Product Code
    OHT,ONF
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K131870
    Predicate For
    K161089,K170269,K171433
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Glide™ device is an over the counter device intended for the removal of unwanted hair. The Glide™ device is also intended for 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

    The Glide device is a pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The Glide device is composed of a hand held applicator. The device contains 6 LEDs indicating 5 different energy levels and other device functions. The spot size in the Glide device is 2.7cm2. The device contains a lamp, a temperature sensor, a skin proximity sensor and a skin color sensor to detect appropriate skin tones. The skin sensor scans darker skin tones and will not pulse if the skin tone is not suitable for treatment.

    AI/ML Overview

    This 510(k) submission (K141242) for the Home Skinovations Glide Device indicates that this device is identical to a previously cleared device (K131870). Therefore, the clinical performance data provided here actually refers to the study conducted for the K131870 submission.

    Here's a breakdown of the acceptance criteria and study information, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state quantitative acceptance criteria in a table format. However, the "Indications for Use" section defines the goal of the device, which implicitly sets the performance target. The reported performance is based on the findings of the clinical study.

    Acceptance Criteria (Implicit from Indications for Use)Reported Device Performance (from Clinical Study)
    Removal of unwanted hair.Hair removal was evaluated.
    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.Follow-up durations of 1 and 3 months after completion of the last treatment were evaluated. (Note: This is shorter than the 6, 9, 12 months criteria but acceptable for this submission as it references a previously cleared device).
    No adverse events related to the treatment.No adverse events related to the treatment were reported.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not explicitly stated for the test set. The document mentions "a prospective clinical study," but does not provide the number of participants.
    • Data Provenance: The study was "prospective," meaning data was collected specifically for the purpose of the study going forward. The country of origin for the data is inferable as likely being Israel, given the applicant and contact persons' addresses, but this is not explicitly stated.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

    This information is not provided in the document. The study simply states "evaluated hair removal," without detailing the method of assessment or the involvement of experts in establishing ground truth.

    4. Adjudication Method for the Test Set

    This information is not provided in the document.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

    A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a clinical study evaluating the device's performance, not a comparison of human readers with and without AI assistance. The device itself is a "pulsed light hair removal device," not an AI diagnostic tool.

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

    This question is not applicable as the device is a physical hair removal device, not an algorithm.

    7. The Type of Ground Truth Used

    The type of ground truth is implicitly the observed hair regrowth/removal from the facial skin of participants in the clinical study. The method of quantifying this observation (e.g., hair counts, photographic assessment by experts) is not detailed.

    8. The Sample Size for the Training Set

    This question is not applicable as the device is a physical hair removal device, not an algorithm that requires a training set in the typical AI sense.

    9. How the Ground Truth for the Training Set was Established

    This question is not applicable, as there is no "training set" in the context of this physical device.

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