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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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The Voyant Open Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures where the ligation and division of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.

The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Voyant® Open Fusion is an advanced bipolar instrument that uses radiofrequency (RF) energy, provided by the Voyant Electrosurgical Generator (Voyant ESG), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. Once the tissue is fused, the sealed tissue may be divided with a user-actuated blade to transect the tissue at the seal site.

The Voyant Open Fusion is comprised of three sections: jaws, shaft, and handle (including the cord and device plug). The subject device features a curved jaw with a tapered jaw design. The updated tapered jaw design does not change the device's intended function or user interface. The pistol-grip style handle features a knob, fuse button, trigger, and blade lever. The knob enables 180° rotation of Voyant Open Fusion device jaws. The trigger opens and closes the device jaws and can latch when the jaws are in the closed position. Squeezing the trigger again will release the latch and allow the jaws to open. The fuse button on the back of the handle activates RF energy. When the fuse button is pressed and held for the full seal cycle, RF output will automatically stop upon a complete seal, an audible tone will be heard and a message is displayed on the Voyant ESG screen. If the user releases the button prior to seal completion, RF output will be interrupted, an alarm tone will be heard and a message is displayed on the ESG screen. To transect the tissue, the user pulls the blade lever while the jaws are latched in the closed position.

The device connects to the Voyant ESG via a device plug and cord. The cord and device plug are attached to the device handle. The cord facilitates the transfer of RF energy from the ESG, through the handle, along the shaft, and to the jaws. The device plug has a distinct shape which enables a proprietary connection to the Voyant ESG.

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Advanced Bipolar: The Voyant electrosurgical generator is indicated for use with advanced bipolar Voyant devices in open and minimally invasive procedures where the ligation of vessels up to and including 7mm in diameter and tissue bundles is desired.

NOTE: For indications specific to each Voyant device used with the Voyant generator, refer to each device's Instructions for Use (IFU).

Monopolar/Bipolar: Intended to provide energy to standard monopolar and bipolar surgical accessories.

The Applied Medical Voyant Electrosurgical Generator (EA030) is a reusable, electrically isolated, microprocessor-controlled power supply intended to deliver radiofrequency (RF) energy for electrosurgical applications. The system provides energy output to compatible monopolar, bipolar, and Voyant advanced bipolar instruments for the cutting, coagulation, and sealing of vessels and tissue bundles. The Voyant EA030 operates outside the sterile field and interfaces with active surgical instruments that operate within the sterile field. The system comprises integrated mechanical, electrical, and software components, constructed from various metals and polymers. It features a front-panel LCD touchscreen that enables users to view, navigate and adjust operating modes and system settings.

Voyant EA030 is designed to function as part of a system that includes optional accessories such as active devices, footswitches, and patient return electrodes. These components work together to ensure safe and effective energy delivery during surgical procedures.

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The PrecisePath Radiofrequency Puncture Generator and Footswitch (optional accessory) is indicated for use in general surgical procedures to cut and coagulate soft tissues.

The PrecisePath Radiofrequency (RF) Puncture Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue. It is designed to be used by trained medical professionals, to provide radiofrequency (RF) current for creating controlled punctures with compatible Baylis RF devices in a monopolar mode. This continuous or pulsed RF current is output at a fixed frequency within 450 kHz to 480 kHz.

The PrecisePath Footswitch (optional accessory) may be used as an alternative to the on/off button on the generator user interface by which the user can start and stop the delivery of RF energy.

The PrecisePath RF Puncture Generator is compatible with separately cleared Baylis radiofrequency devices and connector cables, off-the-shelf return (dispersive) electrodes that meet or exceed IEC 60601-2-2:2017, and the PrecisePath footswitch (optional accessory).

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ArtiSeal Vessel Sealing System - ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use only with the ArtiSeal Generator in minimally invasive or open surgical procedures where ligation (sealing) and division (Cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery.

The ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) is a sterile, single-use, invasive instrument which is used with electrosurgical generator (ArtiSeal Generator), intended to be used during laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels and tissue bundles is desired.

When activating the sealing button of ArtiSeal Vessel Sealing System-ArtiSeal instruments, the ArtiSeal Generator applies radiofrequency (RF) energy to the electrode portion of the jaw. Heat is generated from the electrode for ligation.

During surgical procedures, the user operates the grip lever to open and close the jaw. Furthermore, the jaw can be bent up, down, left, and right within a range of up to ±90° or more by adjusting the grip accordingly. The jaw also provides 360° articulation (rotation) by turning the grip.

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Coolfase is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Coolfase is electrosurgical unit that high-frequency current for tissue coagulation during treatment. It consists of an electrosurgical unit main body, a handpiece, and a tip, and is used in conjunction with a grounding pad, coupling gel, and a foot switch. The high-frequency current generated by the main body is delivered to the skin through the handpiece connected to the tip. The electrical resistance of the skin generates heat, and this heat coagulates the tissue.

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The InbellaMulti System with the Non-invasive Applicators employs RF energy for various applications:

• i-BellaForma, BellaForma, BellaPlus and BellaPlus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.

• BellaWMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids.

• BellaBodyFX /BellaMiniFX for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.

The InbellaMulti System with the Fractional Applicators employs RF energy for various applications:

• BellaFractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.

• BellaFractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

• BellaM8 for dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

The InbellaMulti System supports multiple radiofrequency (RF) applications and accessories. The InbellaMulti System is compatible with the Fractional RF Applicators and the Non-Invasive RF Applicators, and employs RF energy for various applications. The InbellaMulti System consists of a platform console with an AC/DC power supply unit, two applicator connectors, RF generator, RF measuring circuit, controller, footswitch and user interface including a touch screen. The RF Applicator is connected to the console via a cable and a footswitch activates the energy delivery to the applicator. The applicators are comprised of a handle and electrodes, and some of them are used with a single-use tip. The below list comprises the set of applicators to be registered under the subject device:

• i-BellaForma
• BellaForma
• BellaPlus
• BellaPlus90
• BellaWMFace
• BellaBodyFX
• BellaMiniFX
• BellaFractora with 60 pins tip
• BellaFractora with 24 pins tip
• BellaM8 with the following tip heads: Resurfacing (T), Prime (12-pin), 24-pin, 40-pin (Body)

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