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510(k) Data Aggregation

    K Number
    K103184
    Date Cleared
    2010-11-10

    (12 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    SILK'N FLASH N GO

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

    Flash N Go is an over the counter device intended for the removal of unwanted hair. Flash N Go is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.

    Device Description

    The Flash N Go hair removal system is a pulsed light system composed of a base unit and hand held applicator.

    AI/ML Overview

    The provided text describes the 510(k) summary for the Silk'n Flash N Go hair removal device. However, it does not contain the specific details required to answer your request regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, or specific study results.

    The document only states:

    • "Clinical data was collected in a prospective multisite clinical study."
    • The intended use includes "permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime."
    • The device complies with "21CRF § 1040.10 & 1040.11" (performance standards for light-emitting products).

    The requested information (acceptance criteria table, sample sizes, ground truth details, MRMC study, standalone performance) is not available in the provided text. This type of detailed performance data and study design would typically be found in the full 510(k) submission or an associated clinical study report, which is not included here.

    Therefore, I cannot fulfill your request with the given input.

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