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510(k) Data Aggregation

    K Number
    K162231
    Device Name
    iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert
    Manufacturer
    CYDEN LIMITED
    Date Cleared
    2016-11-16

    (100 days)

    Product Code
    OHT,GEX
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert

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

    The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse Smoothskin Gold 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

    The provided text is a 510(k) clearance letter from the FDA for the "Ibulse Smoothskin Gold Hair Removal Device". It does not contain any information regarding acceptance criteria, device performance metrics, sample sizes, expert qualifications, or study design details.

    Therefore, I cannot extract the requested information. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance study results.

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