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510(k) Data Aggregation

    K Number
    K171707
    Device Name
    GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A
    Manufacturer
    Gowoonsesang Cosmetics Co., Ltd
    Date Cleared
    2017-08-08

    (61 days)

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

    Gowoonsesang Cosmetics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single Use RF electrode (Needle Type) is a monopolar electrosurgical electrode indicated for coagulation of soft tissue when it used in conjunction with compatible radio frequency electrosurgical device.
    Device Description
    Single Use RF Electrode (Needle Type) consists of conductive electrode part, insulation coated part and conductive post part. There are several models (Models: GA-B, GA-C, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A) according to the total size and needle electrode part size. The conductive post of electrode is inserted into the head of the intended handpiece to receive the radio frequency current and delivers the current to a target tissue for coagulation in electrosurgical procedure. This device is a monopolar RF electrosurgical electrode used in conjunction with radio frequency electrosurgical device and a neutral electrode plate which complies with IEC 60601-1 and IEC 60601-2-2. It is intended to be used exclusively with the ESU cleared in K160469, Model: AGNES.
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    K Number
    K160469
    Device Name
    AGNES
    Manufacturer
    GOWOONSESANG COSMETICS CO., LTD
    Date Cleared
    2017-01-05

    (321 days)

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

    GOWOONSESANG COSMETICS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a hand-piece, Single use RF electrodes (needle type). Disposable neutral electrode pad and a footswitch.
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