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510(k) Data Aggregation

    K Number
    K231514
    Device Name
    Azure
    Date Cleared
    2024-02-14

    (265 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Daeshin Enterprise Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Azure(DS-22CO) is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry.
    Device Description
    Azure consists of main body, articulated arm, handpiece, foot switch, power cord, protective glasses. In a main body, there are a monitor displaying all information needed by an operator at a glance and a touch LCD manipulated by simple hand touch, which facilitates operation of the equipment at user's convenience. The laser output is released by the foot switch. This laser operation device uses CO2 medium based wave of 10.6 micrometers.
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