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510(k) Data Aggregation

    K Number
    K253219

    Validate with FDA (Live)

    Device Name
    LeafPure-Echo (LM-LPNdA)
    Manufacturer
    Shenzhen Leaflife Technology Co., Ltd.
    Date Cleared
    2025-11-25

    (57 days)

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

    The LeafPure-Echo is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

    1064nm wavelength:

    • Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colours: black, brown, green, blue and purple.
    • Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

    532nm wavelength:

    • Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colours: red, yellow and orange.
    • Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
    Device Description

    Not Found

    AI/ML Overview

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