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510(k) Data Aggregation

    K Number
    K241099
    Device Name
    Plasonic (Plasonic)
    Manufacturer
    Hironic Co., Ltd.
    Date Cleared
    2024-11-08

    (200 days)

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

    Hironic Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PLASONIC with PLAPASS handpiece (Radiofrequency) is intended for the removal and destruction of skin lesions and coagulation of tissue. The PLASOINC with SONOPASS handpiece (Ultrasound) is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques.
    Device Description
    The device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, two handpieces, foot switch, LCD touchscreen and power cable. The PLASONIC has two systems (two handpieces) : - 1) Radiofrequency (PLAPASS Handpiece) The device is intended for the removal and destruction of skin lesions and coagulation of tissue. The system is intended for use by trained healthcare professionals in a clinical setting to provide controlled radiofrequency therapy through non-invasive procedure. - 2) Ultrasound (SONOPASS Handpiece) The device is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques. The device is designed to deliver therapeutic ultrasound waves, promoting tissue relaxation and aiding in the recovery process for improved patient well-being
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    K Number
    K233123
    Device Name
    SILKRO
    Manufacturer
    Hironic Co., Ltd.
    Date Cleared
    2024-06-24

    (271 days)

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

    Hironic Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SILKRO with RM. RN. RC. RV. PS handpieces is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The SILKRO with RN handpieces is intended for the removal and destruction of skin lesions and coagulation of tissue.
    Device Description
    This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, five handpieces, GP Cable, foot switch, LCD touch screen, ground pad and power cable. The SILKRO has two operating modes: monopolar mode and bipolar mode. In the monopolar mode. RF energy flows from the main unit and a patient loop is formed by pairing the active electrode tip with the neutral electrode pad. Heat is not generated in the neutral electrode pad due to its low contact resistance, but heat is generated in the active electrode tip which has higher contact resistance. The higher contact resistance heats up the tissue resulting in coagulation. In the bipolar mode, RF energy is delivered between adjacent needles in the electrode tip without use of the neutral electrode pad. The user can select the mode and adjust parameters through the touch screen user interface of electrosurgical device. RF(HF) enerqy is delivered to the target tissue using a handpiece (RM, RN, RC, RV, PS) and 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 RF(HF) energy passes through the skin, it generates an electro RF reaction which is capable of coagulating the tissue. - Electrosurgical Unit Main body - Five different handpieces - Neutral electrode pad and neutral electrode pad cable, cleared under K092761 - Handpiece stands - Foot switch - Power cord
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    K Number
    K201773
    Device Name
    PICOHI
    Manufacturer
    Hironic Co., Ltd.
    Date Cleared
    2021-10-19

    (477 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hironic Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PICOHI is indicated for the following at the specified wavelength: - · 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. - · 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. - · Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
    Device Description
    The PICOHI is a solid-state laser capable of delivering energy at wavelengths of 1064nm, 532nm at extremely short duration in the range of 275-300ps. The laser system contains one 1064nm (Nd:YAG) laser head which is used to create the 1064nm picosecond wavelength which can be frequency-doubled to 532nm as desired. The outputs of the two lasers are designed to be colinear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 1064nm or 532nm wavelengths. All these energies are delivered through an articulated arm and corresponding handpiece.
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    K Number
    K173676
    Device Name
    A-FIT
    Manufacturer
    HIRONIC Co., Ltd.
    Date Cleared
    2018-09-14

    (288 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    HIRONIC Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Main Hand Piece For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia Radio Frequency Hand piece The RF Hand piece energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
    Device Description
    A-FIT consists of Laser diode and high-frequency (RF) stimulator. It can be used for incision, destruction and removal of skin tissue by illuminating a 1450 nm wavelength laser on the skin tissue. In addition, the RF energy can be used to relieve pain. Laser surgical unit, diode: Specifically, a 1450 nm wavelength laser is absorbed into the skin to be transformed into thermal energy, which then induces incision, destruction and removal of skin tissues. Laser is sent out through the power unit equipped inside the Main Body to oscillate the laser diode, and the user uses the touch LCD in the Main Body to set the output parameters while controlling laser radiation through the foot switch. At this point, a coolant is sprayed from the end of the hand piece to protect skin from the heat generated by the radiated laser, resulting in a reduction in skin irritation and pain. Electrosurgical system, general-purpose: The operating concept of the electrosurgical unit is to let the high frequency (RF) energy flow through the electrodes of the hand piece to use the load or heat generated by contact resistance, resulting in a coagulant activity on the cell tissues.
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