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510(k) Data Aggregation

    K Number
    K242469
    Device Name
    RFMagik Lite
    Manufacturer
    Agnes Medical Co., Ltd
    Date Cleared
    2025-04-25

    (248 days)

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

    Agnes Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    RFMagik Lite is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch. There are two handpieces. RO handpiece and AGNES RF handpiece that delivers RF energy through the disposable electrode in the handpiece.
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    K Number
    K230837
    Device Name
    PlazMagik
    Manufacturer
    Agnes Medical Co., Ltd
    Date Cleared
    2024-02-29

    (339 days)

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

    Agnes Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PlazMagik is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The AGNES MEDICAL CO.,LTD PlazMagik is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin to that part or all or the epidermis becomes non-viable and there is controlled damage to the underlying dermis. The PlazMagik system consists of a system console, footswitch, Two type of handpiece and tip guide.
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    K Number
    K223805
    Device Name
    Agnes
    Manufacturer
    Agnes Medical Co., Ltd
    Date Cleared
    2023-05-04

    (136 days)

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

    Agnes Medical 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 footswitch, a hand-piece, single use RF electrodes and FDA cleared Disposable neutral electrode pad (K102372).
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    K Number
    K203013
    Device Name
    AGNES
    Manufacturer
    Agnes Medical CO., LTD
    Date Cleared
    2022-07-14

    (651 days)

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

    Agnes Medical 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 footswitch, a hand-piece, single use needle type RF electrodes and FDA cleared Disposable neutral electrode pad (K102372).
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    K Number
    K192728
    Device Name
    Agnes
    Manufacturer
    Agnes Medical Co., Ltd
    Date Cleared
    2019-10-24

    (27 days)

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

    Agnes Medical 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 footswitch, a hand-piece, FDA cleared Single use needle type RF electrodes (K171707) and FDA cleared Disposable neutral electrode pad (K102372).
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