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510(k) Data Aggregation

    K Number
    K222369
    Device Name
    PURE Laser
    Manufacturer
    Endymed Medical, Ltd.
    Date Cleared
    2022-10-07

    (63 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K193367
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Indications for use for the Pure Laser diode hair removal system with a 810nm applicator include:

    • · Hair removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
    • · Treatment of Pseudo folliculitis Barbae (PFB)
    • · Use on all skin types (Fitzpatrick I-VI)
    Device Description

    The PURE Laser system is a non-invasive diode laser based system used for Hair Removal. The system is based on a single wavelength laser diode built-in a HP, with a 10x10mm spot size and ability to control the pulse width, frequency and power. The Hair Removal Laser is intended for use on all skin types (Fitzpatrick skin types I-VI).

    The device is sold with an electroconductive gel with prior FDA clearance – EndyGel (K161715).

    AI/ML Overview

    This document (K222369) is a 510(k) summary for the PURE Laser, a device intended for hair removal. It does not contain information about the performance of an AI/ML device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device.

    The document primarily focuses on demonstrating substantial equivalence to a predicate device (Elysion-pro (K193367)) based on technological characteristics and adherence to safety and performance standards for laser equipment. It explicitly states that "No clinical studies were conducted as part of this submission."

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