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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
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    Matched: '878.5350'

    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
    K223805
    Device Name
    Agnes
    Manufacturer
    Agnes Medical Co., Ltd
    Date Cleared
    2023-05-04

    (136 days)

    Product Code
    GEI, KCW
    Regulation Number
    878.4400
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    Matched: '878.5350'

    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?
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    Matched: '878.5350'

    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?
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    Matched: '878.5350'

    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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    K Number
    K182355
    Device Name
    Secret RF Smartcure Applicator with electrodes
    Manufacturer
    Ilooda Co., Ltd.
    Date Cleared
    2019-09-06

    (372 days)

    Product Code
    GEI, KCW, ONQ, OUH
    Regulation Number
    878.4400
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    Matched: '878.5350'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Secret RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
    Device Description
    Secret RF's High Frequency(=Radio Frequency) includes the system main body, a handpices with singleuse micro-needle type electrodes, footswitch and an LCD touch screen control panel. The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip. The Secret RF is consists of ; - 1) Secret RF main unit (FDA cleared K170325) - 2) Bipolar type handpieces with Bipolar type micro-needle electrodes (FDA cleared K170325) - 3) Secret RF Smartcure applicator The Secret RF Smartcure Applicator consists of : - Smartcure handpiece - Monopolar type micro-needle electrodes (MTR-AC-01 , MTR-AC-04, MTR-AC-27G, K3i)
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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
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    Matched: '878.5350'

    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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    K Number
    K021149
    Device Name
    AURORA DS
    Manufacturer
    SYNERON MEDICAL LTD.
    Date Cleared
    2002-07-09

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
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    Matched: '878.5350'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aurora DS is intended for use in dermatology for non invasive hair removal. The Aurora DS is indicated for non-invasive hair removal.
    Device Description
    The Aurora DS is a device that is used for non-invasive hair removal. The Aurora DS treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) hair and follicle without damaging the surrounding tissues.
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