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510(k) Data Aggregation

    K Number
    K213692
    Device Name
    SmoothSkin Pure Mini
    Manufacturer
    CyDen Limited
    Date Cleared
    2022-01-26

    (64 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 :

    SmoothSkin Pure Mini

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

    The SmoothSkin Pure Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin Pure Mini 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) premarket notification letter from the FDA to CyDen Limited for their device, SmoothSkin Pure Mini, a hair removal device. This document primarily focuses on the FDA's determination of substantial equivalence and regulatory compliance.

    It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is regulatory approval, not a scientific study report.

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