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510(k) Data Aggregation

    K Number
    K252515
    Device Name
    Q-Switched Nd:Yag laser (K690)
    Manufacturer
    HEBEI KEYLASER SCI-TECH Co.,Ltd
    Date Cleared
    2025-11-06

    (87 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K202758
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Q-Switch Nd:Yag laser is intended for use in removal of dark ink (black, blue and brown) tattoo, removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma, removal or lightening of unwanted hair with or without adjuvant preparation, skin resurfacing procedures for the treatment of acne scars and wrinkles.

    Device Description

    Q-Switched Nd:Yag laser consists of a main engine, controller, power control switch, optical system and power input panel. A multifunctional microcomputer can control and adjust the size of the laser spot, making it suitable for treating diseases in different parts of the body. Parameters such as the laser energy required for the treatment can be set by the user appropriately.

    AI/ML Overview

    N/A

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