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510(k) Data Aggregation

    K Number
    K233120
    Device Name
    CWM-930S, FIXER DV9
    Manufacturer
    Date Cleared
    2024-05-23

    (239 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chungwoo Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended for use in dermatologic and general surgical procedures for electro coagulation.
    Device Description
    This device is a Fractional RF Surgical Unit with Sterile Micro Needle, which is composed of the main device (generator and user interface display, handpiece, foot switch, neutral electrode, and monopolar microneedle electrodes. It is designed for applying radiofrequency therapy with microneedles, which coagulates skin tissue using 1 MHz or 2 MHz radiofrequency energy delivered from the generator to the microneedles. A Bipolar Handpiece suction filter is also available for use to remove unwanted debris from the skin application site and safeguarding the equipment by preventing foreign substances from entering during use.
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    K Number
    K222709
    Device Name
    Retraction, CWM-910T, APOLEX Tite
    Manufacturer
    Date Cleared
    2023-03-21

    (194 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chungwoo CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    Retraction, CWM-910T and APOLEX Tite are RF electrosurgical system. These are identical except for model designation. The RF electrosurgical system consists of an electrosurgical device (ESU), 3 types of detachable handpieces (mono-polar active electrode), a grounding plate (neutral electrode) and a foot switch. The hand piece consists of a hand grip and an electrode. There are 3types of mono-polar electrode depend on diameter and length. The electrosurgical device generates 480KHz RF current. RF output energy (Max. 50W) is delivered through a mono-polar active electrode and returned through the grounding plate (neutral electrode).
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