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510(k) Data Aggregation

    K Number
    K253920

    Validate with FDA (Live)

    Date Cleared
    2026-03-03

    (85 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K202250

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

    The CO2 Laser Treatment Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology,podiatry,dental and otorhinolaryngology.

    Device Description

    The device emits CO2 laser at the wavelength of 10.6µm, which is the spectral line in the far infrared range. The device is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. Carbon dioxide laser 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. Cutting, vaporization, carbonization, solidification and irradiation. 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.

    AI/ML Overview

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