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510(k) Data Aggregation

    K Number
    K213612
    Device Name
    SYLFIRM X
    Manufacturer
    VIOL Co., Ltd.
    Date Cleared
    2022-06-23

    (220 days)

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

    VIOL Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SYLFIRM X™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis.
    Device Description
    The SYLFIRM X™ includes a system main device, a hand-piece equitable with a bi-polar electrode, and a foot switch. The RF signal is generated from the main device which is then delivered to the handpiece and then to bi-polar electrode. The RF signal is delivered to the target tissue using penetrating needle electrodes in the consumable tip. The bi-polar electrode is placed in light contact with the epidermis while the hand-piece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, SYLFIRM X™ creates heat within the target skin tissue via needle electrodes from the bi-polar electrode.
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    K Number
    K200185
    Device Name
    SYLFIRM X
    Manufacturer
    Viol Co., Ltd.
    Date Cleared
    2020-04-22

    (89 days)

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

    Viol Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SYLFIRM X™ is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The SYLFIRM X™ includes a system main device, a probe equitable with a consumable tip, and a foot switch. The RF signal is generated from the main device which is then delivered to the probe and then to consumable tip. The RF signal is delivered to the target tissue using penetrating needle electrodes in the consumable tip. The consumable tip is placed in light contact with the epidermis while the probe is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, SYLFIRM X™ creates heat within the target skin tissue via needle electrodes from the consumable tip.
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    K Number
    K180872
    Device Name
    SCARLET SRF
    Manufacturer
    Viol Co., Ltd.
    Date Cleared
    2018-10-11

    (191 days)

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

    Viol Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SCARLET SRF is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The SCARLET SRF includes a system main device, a hand-piece equipped with a tip, and a footswitch. The RF signal is generated from the main device which is then delivered to the handpiece and then to consumable tip. The RF signal is delivered to the target tissue using penetrating needle electrodes in the tip. The tip is placed in light contact with the epidermis while the handpiece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, SCARLET SRF creates heat within the target skin tissue via needle electrodes from the consumable tip.
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    K Number
    K172023
    Device Name
    CELFIRM
    Manufacturer
    VIOL Co., Ltd.
    Date Cleared
    2017-10-13

    (100 days)

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

    VIOL Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CELFIRM™ is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The CELFIRM™ includes a system main device, a hand-piece equipped with a tip, and a footswitch. The RF signal is generated from the main device which is then delivered to the hand-piece and then to consumable tip. The RF signal is delivered to the target tissue using penetrating needle electrodes in the tip. The tip is placed in light contact with the epidermis while the hand-piece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, CELFIRM™ creates heat within the target skin tissue via needle electrodes from the consumable tip.
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