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510(k) Data Aggregation

    K Number
    K150409
    Device Name
    VIVACE Electrosurgical System
    Manufacturer
    Sung Hwan E&B Co.,Ltd
    Date Cleared
    2016-01-15

    (331 days)

    Product Code
    OUH
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    OUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. This Vivace Electrosurgical System is intended for use with Skin Type I to Skin Type V.
    Device Description
    The VIVACE Electrosurgical System is comprised of the following components: the system main body of the device which consists of the LCD touch screen control panel, the high frequency generating output section (main P.C.B board or RF Generator), and the power supply component, the Switching Power Supply (SMPS). The accessories to the device include the handpiece with disposable micro-need le cartridge (electrode) insertion, and foot switch. Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. The hand piece being held at right angles, the tip is placed in light contact with the epidermis. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator, hand piece are not disposable. Each disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be resterilized.
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    K Number
    K142833
    Device Name
    INTRAGen
    Manufacturer
    JEISYS MEDICAL, INC.
    Date Cleared
    2015-06-04

    (247 days)

    Product Code
    OUH, GEI
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    OUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INTRAgen is intended for dermatologic and general surgical procedures for electro coagulation and hemostasis.
    Device Description
    The INTRAgen uses the principle that coagulation of cellular tissue is caused using the heat generated by the load or contact resistance by carrying high frequency current to the body. Active electrodes of INTRAgen have 2 types according to effective area: model KT-07 (7 mm x 7 mm) and model KT-15 (15 mm x 15 mm). Electrical current flows through the tip of the electrode, through the target tissue and to the patient plate. The active electrodes are for single use. Patient contacting materials are PCB (Polychlorinated Biphenyl) and ABS (Acrylonitrile-Butadiene-Styrene Copolymer). The INTRAgen consists of the following components: INTRAgen (Main Frame), Active Accessory : Active Electrode(KT-07 (7 mm x 7 mm), KT-15 (15 mm x 15 mm)), Handpiece Hanger and Hand-piece, Miscellaneous Accessories : Foot Switch and Power Cable.
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    K Number
    K130501
    Device Name
    INTENSIF
    Manufacturer
    ENDYMED MEDICAL LTD
    Date Cleared
    2014-03-13

    (379 days)

    Product Code
    OUH, GEI
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    OUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
    Device Description
    EndyMed's Intensif Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346) (EndyMed Pro). The Intensif Applicator has a custom grid array of micro electrodes that is used to deliver the energy into the tissue. The Intensif Applicator tip emits bipolar RF energy that flows between electrodes to create thermal heating of the tissue for hemostasis and coagulation. The Intensif Applicator consists of: . Disposable treatment element (tip) . RF electrodes on a disposable tip . Operation trigger.
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    K Number
    K120513
    Device Name
    GLOW BY ENDYMED
    Manufacturer
    ENDYMED MEDICAL LTD
    Date Cleared
    2012-05-08

    (77 days)

    Product Code
    OUH, GEI
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    OUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glow by EndyMed is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The TC applicator is indicated for mild to moderate facial wrinkles and rhytides. The FSR applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin.
    Device Description
    The EndyMed Glow is a non-invasive unit consists of a user interface, programmable logic controller (PLC), an RF power module, internal electronics, and treatment handpieces. The user interface allows the selection of treatment parameters by pressing on the treatment buttons; A LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety functions of the system. The system is connected to one or two out of 2 TC handpieces with different size electrode areas for different treatment sites, or to a FSR handpiece. The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at 1MHz frequency.
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    K Number
    K101510
    Device Name
    FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR
    Manufacturer
    ENDYMED MEDICAL LTD
    Date Cleared
    2011-02-17

    (261 days)

    Product Code
    OUH
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    OUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fractional Skin Resurfacing (FSR) Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin
    Device Description
    EndyMed's Fractional Skin Resurfacing (FSR) Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346). The FSR Applicator tip emits bipolar RF energy that flows between electrodes to create micro-ablation points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis.
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