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510(k) Data Aggregation

    K Number
    K252519

    Validate with FDA (Live)

    Date Cleared
    2025-11-07

    (88 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CO2 Laser Therapy System is used for soft tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

    Device Description

    CO2 Laser Therapy System is a laser beam generated by electrically excited carbon dioxide gas molecules, which has a very small divergence angle and high energy density. After focusing, it can reach a power of several kilowatts per square centimeter. Has the functions of vaporization and coagulation. The unfocused original light beam irradiates the lesion tissue, which can cause coagulation of biological tissue. The CO2 laser penetrates the tissue deeper, and after irradiation, it can heat and treat the deep tissue.

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    K Number
    K252515

    Validate with FDA (Live)

    Date Cleared
    2025-11-06

    (87 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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.

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