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The ZenTite is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The ZenTite is used for the relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation.

The ZenTite system consists of a host, a footswitch, a power cord, handpieces (optional) and electrodes (optional). The treatment handle includes a handpiece, a sterilized or not sterilized electrode. There are three types of handpieces and each type is connected with one selected electrode. They are MicroRF handpiece connected with MicroRF series electrodes (MicroRF 49, MicroRF 25, MicroRF 9N, MicroRF 25N), Artist handpiece connected with Artist series electrodes (Artist D2.0, Artist D3.5, Artist D4.5, Artist D6.0) and Pure+ handpiece connected with Pure+ B1 electrode.

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The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, dissection, incision, and hemostasis in soft tissue surgical procedures

The Soniquence 3-Button Fingerswitch Wand is an accessory intended for use with the Soniquence SmoothWave RF Generator. The device connects to a high-frequency generator via a male connector, and the distal female connector interfaces with a compatible Soniquence monopolar electrode. The device is supplied non-sterile and is intended for use with Soniquence monopolar electrodes.

The 3-Button Fingerswitch Wand provides user access to three monopolar waveforms without the need for generator front-panel manipulation. The handpiece enables activation of CUT, BLEND, and HEMO modes via integrated finger-actuated switches. When a button is depressed, the corresponding mode is activated regardless of the generator display settings. Visual indicators illuminate to confirm activation of the selected mode.

a) The CUT button will activate CUT mode. When depressed, the yellow indicator (CUT) illuminates.
b) The BLEND button will activate BLEND mode. When depressed, the yellow indicator (BLEND) illuminates.
c) The HEMO button will activate the HEMO mode. When depressed, the blue indicator (HEMO) illuminates.

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The Ignite RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.

Morpheus8: At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Burst and Burst Deep Applicator is limited to Skin Types I-IV.

The Ignite RF System is a computerized system generating RF energy for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis.

The Ignite RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpieces are connected to the console via a cable and a foot switch activates the energy delivery to the handpiece. Multiple handpieces are available. The System is compatible with the following handpieces:

• Monopolar ("RFAL") handpieces: These handpieces are comprised of a disposable, single use plastic handle with active internal electrodes and external (return) electrodes. Both internal and external temperature are constantly monitored.

• Bipolar ("Quantum") handpieces: comprised of a disposable, single use plastic handle with active internal bipolar electrodes and no external electrodes. Control of the thermal effect is by selection of delivered amount of energy.

• Morpheus8 Burst/Burst Deep handpieces: the Morpheus8 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The Morpheus8 Applicator comprises a handle and detachable, sterilized, disposable, single-use tip head accessories. Control of the thermal effect is by selection of delivered amount of energy.

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The Irreversible Electroporation (IRE) System Generator is indicated for the surgical ablation of soft tissue, specifically for otorhinolaryngology (ENT) indications.

The ENTire IRE System includes a reusable electrosurgical generator activated by a foot pedal and single-use handpieces which are provided sterile. The ENTire IRE System utilizes irreversible electroporation ("IRE"), a nonthermal ablation technology that delivers high-voltage, low-energy electrical pulses to tissue via bipolar electrodes. The system generates irreversible nanopores in the cell membranes, altering the cell membrane characteristics, and inducing apoptosis. The dead cells are then resorbed leading to tissue reduction.

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The Boston iFace is intended to be used for heating to rise tissue temperature, which is used for selected medical conditions, such as temporary relief of pain, muscle spasms, and promotion of local circulation.

The Boston iFace is mainly composed of a host, a footswitch, a handpiece, a hand swtich, a power cord, tip connectors, tips and a trolley.

The Boston iFace is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field. The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy.

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MOVIVA is intended for:

• argon plasma coagulation and ablation of the mucosa, with or without lesions.
• needle-free injection and tissue-selective hydrodissection including lifting mucosa by injection into the submucosa.

MOVIVA is indicated for use in endoscopic procedures.

MOVIVA is a flexible, sterile, single use monopolar probe that combines the technologies of hydrosurgery and argon plasma coagulation (APC) in one instrument. Each function can be activated independently without the need to change instruments.

It is used with an Erbe hydrosurgical unit and an Erbe APC unit in combination with an electrosurgical unit (ESU) Erbe VIO Model. The probe is inserted via the working channel of an endoscope with a working channel diameter larger than 2.8 mm. A form-coded marking near the probe tip ensures consistent positioning and orientation during the procedure.

The hydrosurgical function is intended to deliver a pressurized fluid to create a fluid cushion beneath the tissue to be ablated which serves as a mechanical and thermal protection layer for the underlying tissue (muscularis). The electrosurgical (i.e. APC) function is intended for ablation of the lifted tissue. MOVIVA has a shaft length of 1.9 meters, a cable length of 3 meters and an outer diameter (OD) of 2.4 mm.

MOVIVA is connected to the units via respective cables/tubing. The settings or adjustment of application parameters is performed via the units. Activation of the instrument is done using a footswitch.

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F Care RF System is intended to conduct radio frequency (RF) current for coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures. The devices are prescription use (Rx) devices.

F Care RF System is designed for thermocoagulation (RF) of tissue by administration of high frequency energy by means of electrosurgical electrodes of soft tissue in a broad range of surgical procedures. The system consists of:

• MedRF4000, electrosurgical generator (00MEDRF4000US)
• Rafaelo probe, electrosurgical electrode (05RAFAELORPROBE)
• Sphera probe, electrosurgical electrode (05SPHERAPROBE)
• Output cable (06OUTPUTKAB)
• Foot pedal (06PedalST1)

The F Care RF System includes the MedRF4000 generator and two sterile, single-use monopolar electrodes. the Rafaelo and Sphera probes designed to deliver high-frequency radiofrequency (RF) energy to soft tissue for coagulation and hemostasis. The system is for prescription use only and intended for trained healthcare professionals.

The MedRF4000 generator, previously cleared under 510(k) K210077, has been modified to remove the USB interface; no other changes have been made to its performance or design. The Rafaelo probe connects directly to the generator, while the Sphera probe connects via a reusable handle. Only one probe is used per procedure. The Rafaelo probe consists of a handle, output cable, and a stainless-steel tube with a sharp, insulated tip. The Sphera probe includes a handle and a rounded, ball-shaped insulated tip. Both feature anti-adhesive coated tips and are intended for external communication with limited (<24-hour) contact duration.

Radiofrequency energy from the generator is delivered through the probe tip and converted into heat in the tissue, causing coagulation. Visual and audible signals from the MedRF4000, including beeps every 2 seconds and energy alerts at 500 J and 1500 J, help track treatment. If these indicators fail, treatment must be stopped to avoid thermal injury.

The Rafaelo and Sphera probes are substantially equivalent to the predicate device HPR45i in design, function, materials, and intended use. Both subject and predicate devices use similar biocompatible materials, are activated via foot pedal, and are EO-sterilized under the same sterilization cycle. They do not have power regulation or diagnostic features.Functionally, the Rafaelo probe is used internally with a sharp tip, while the Sphera probe is used externally with a rounded tip. The Rafaelo probe is packaged in a double sterile pouch, and the Sphera probe in a single sterile pouch. Overall, the F Care RF System, including the updated MedRF4000 and both probes, is safe, effective, and substantially equivalent to the predicate device for soft tissue coagulation in surgical procedures.

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The TS-RF Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue.

The TS-RF Generator consists of an RF generator, cables, and components. This TS-RF Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue. Radiofrequency power is supplied and controlled with a maximum of 50 watts. Data Logs can be stored by connecting the USB Flash Driver with the communication terminal of the rear panel of the RF generator.

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The Venus Nova device is intended for the treatment of the following medical conditions using the 4D Body (MP2) applicator for delivery of RF energy combined with massage and magnetic field pulses:

• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
• Temporary reduction in the appearance of cellulite

When used with the Octipolar (LB1) or Diamondpolar (LF1) applicators, the Venus Nova device is intended for use in dermatologic and general surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.

In addition, the Venus Nova device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles.

The Venus Nova device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

The Venus Nova device using the FlexMAX applicators is intended to be operated by a trained professional.

The Venus Nova device is a computerized device comprised of a console (main unit), one (1) 4D Body applicator containing RF, PEMF and Vacuum, one (1) Octipolar applicator for large anatomical areas containing RF and PEMF, one (1) Diamondpolar applicators for smaller anatomical areas containing RF and PEMF and four (4) FlexMAX applicators containing Electrical Muscle Stimulation (EMS). The device delivers bipolar RF and biphasic electrical energies, vacuum pressure, and pulsed electromagnetic fields (PEMF) to the skin and the underlying tissues of the treatment area. The device provides individual adjustment of EMS intensity level, and RF power, in addition to vacuum levels, for each patient.

The console of the Venus Nova device contains a power supply unit, RF and EMS controllers, (power modules, on main board), a suction module (vacuum), a controller unit (on main board), a touch-screen user interface and display panel.

The applicators are connected to the console via cables. The RF applicators are comprised of various combinations of RF electrodes, magnetic coils, and vacuum conduits. The EMS applicators are comprised of two electrodes each and a light indicator.

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