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510(k) Data Aggregation
K Number
K241099Device Name
Plasonic (Plasonic)
Manufacturer
Hironic Co., Ltd.
Date Cleared
2024-11-08
(200 days)
Product Code
GEI, IMI
Regulation Number
878.4400Why 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
K233123Device Name
SILKRO
Manufacturer
Hironic Co., Ltd.
Date Cleared
2024-06-24
(271 days)
Product Code
GEI
Regulation Number
878.4400Why 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
K210084Device Name
SILKRO
Manufacturer
Hironic Co., Ltd
Date Cleared
2022-06-03
(507 days)
Product Code
GEI, OUH
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Hironic Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for use in dermatologic and general surgical procedures for electro-coagulation.
Device Description
This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, Four handpieces, GP Cable, foot switch, LCD touchscreen, ground pad and power cable. The SILKRO has two operating modes: monopolar mode and bipolar mode.
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K Number
K201773Device Name
PICOHI
Manufacturer
Hironic Co., Ltd.
Date Cleared
2021-10-19
(477 days)
Product Code
GEX
Regulation Number
878.4810Why 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
K192970Device Name
SLIMUS
Manufacturer
HIRONIC Co., Ltd
Date Cleared
2020-12-01
(405 days)
Product Code
PKT, ISA
Regulation Number
878.5400Why did this record match?
Applicant Name (Manufacturer) :
HIRONIC Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SLIMUS is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
Vibrator installed inside each hand-piece and operable only in non-laser output condition is intended for relief from minor muscle aches and pains.
Device Description
The SLIMUS device incorporates a laser system that emits a 1060 nm wavelength using a diode laser. Laser radiation is emitted from the laser main unit to the device's handpieces through the handpiece fibers. The device is used to noninvasively reduce the size of the waist of overweight patients with a Body Mass Index (BMI) of less than 30 (kg/m²). A vibrator function is installed inside of each hand-piece and operable only in non-laser output mode. The device's handpieces are fixed to a belt which then combined provide mechanical vibration to the patient in order provide relief from minor muscle aches and pains.
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K Number
K173676Device Name
A-FIT
Manufacturer
HIRONIC Co., Ltd.
Date Cleared
2018-09-14
(288 days)
Product Code
GEX
Regulation Number
878.4810Why 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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