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510(k) Data Aggregation

    K Number
    K260257

    Validate with FDA (Live)

    Device Name
    CO2 Laser System
    Date Cleared
    2026-03-28

    (59 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 System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

    Device Description

    The working principle of CO2 laser system instrument is that the laser power supply drives the laser emitter to emit light, through the refraction of several mirrors, the light is transmitted to the treatment head, and then the light is aggregated into one point by the focusing mirror, which can reach a very high temperature, so that the treatment area can be sublimated into gas in an instant, so as to achieve the purpose of treatment.

    The CO2 laser system comprises essential components including the main unit, treatment handpiece, foot switch, and various accessories. The wavelength of CO2 laser system is 10600nm.

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