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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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Cedar™ Endovenous Radiofrequency Catheters:
Cedar™ Endovenous Radiofrequency Catheters are intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Endovenous Radiofrequency Generator:
The Endovenous Radiofrequency Generator is used with radiofrequency catheters intended for vessel coagulation.

Like the predicate device, the Cedar Endovenous Radiofrequency Catheters are sterile, single use, disposable radiofrequency (RF) catheters with an integrated connection cable. The catheter has a 7F profile with a heating element (coil) available in two lengths, 3cm and 7cm with a 2.15mm diameter. The catheters include a 60cm working length and catheter positioning is achieved via the heating element with engraved marker. The catheter's function is to provide thermal energy to the desired treatment site through radiofrequency heating from the catheter heating element. The Cedar catheter is designed to be used with the Acotec Endovenous Radiofrequency Generator which is designed to provide controlled delivery of RF energy.

The Endovenous Radiofrequency Generator is designed to provide controlled delivery of radiofrequency (RF) energy to RF catheters marketed by Acotec intended for vessel coagulation. The RF generator supplies and controls the RF energy delivered to the catheter and measures and displays RF output power and elapsed time of RF delivery. The generator also interfaces with a sensor in the catheter to provide a continuous display of measured patient temperature prior to and during RF delivery.

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The Electrosurgical & Ultrasonic Generator (USG-410) is intended to be used with the THUNDERBEAT Transducer, the SONICBEAT Transducer, the THUNDERBEAT or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.

The Reusable Cordless Transducer (TD-410) is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.

The THUNDERBEAT II Shears with Ultrasonic Mode (TB2-0520FC, TB2-0525FC, TB2-0535FC, TB2-0545FC) are intended to be used for open, laparoscopic, and endoscopic surgery to cut, seal, coagulate, grasp, and dissect.

The THUNDERBEAT II Shears with Ultrasonic Mode are indicated for general, plastic and reconstructive, gynecologic, urologic, thoracic, and other open, laparoscopic and endoscopic procedures.

The THUNDERBEAT II Shears with Ultrasonic Mode have been designed to seal and cut vessels up to and including 7mm in diameter, tissue bundles and lymphatics using with the Seal & Cut mode or the Seal mode.

The THUNDERBEAT II shears with Ultrasonic Mode have been designed to seal and cut vessels up to and including 3mm in diameter, tissue bundles and lymphatics using with the Ultrasonic mode.

The following devices are the subject of this premarket (510(k)) submission:

• THUNDERBEAT II (Model Numbers: TB2-0545FC, TB2-0535FC, TB2-0525FC, TB2-0520FC) – Hand instruments used with an ultrasonic generator and transducer capable of sealing, cutting, grasping and dissecting vessels, tissue bundles, and lymphatic tissue up to 7mm in diameter during open, laparoscopic, and endoscopic surgical procedures. THUNDERBEAT II hand instruments are available in four (4) shaft sizes: 20cm, 25cm, 35cm, and 45cm.

• Reusable Cordless Transducer (Model Number: TD-410) – A transducer used with the THUNDERBEAT II hand instruments and ultrasonic generator to dissect and/or coagulate soft tissue, or ligate (seal and cut) soft tissue.

• Ultrasonic Bipolar Generator (Model Number: USG-410) – An ultrasonic bipolar generator used with the compatible hand instruments and transducers to dissect and/or coagulate soft tissue, or ligate (seal and cut) soft tissue. Identical and unchanged from K211838, but modified when accessory MAJ-2467 is used to upgrade USG-410 software version to allow compatibility with THUNDERBEAT II hand instruments.

• Update Tool for USG-410 (Model Number: MAJ-2467) – A function activation portable memory key accessory used to upgrade the software version of USG-410 to allow compatibility with THUNDERBEAT II hand instruments.

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The E Blator is intended for general arthroscopic applications, which include cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator via a standard active lead and a standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution.

The device is equipped with a patented stainless steel electrode tip encased in a thermal insulator. When used in combination with a compatible electrosurgical generator, the device provides radio frequency (RF) energy for cutting, vaporizing, and coagulating soft tissue. The device enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect with handswitch control, said current then returns back to the electrosurgical unit through the return electrode and connector. This provides the capability for the surgeon to balance tissue dissection and hemostatic effects as needed during a given surgical case. For aspirating models, when coupled with a vacuum system, the surgical field can be cleared of undesirable debris simultaneously by using the aspiration port located at the bottom of the face of the electrode. Removing this debris can facilitate the surgeon's visualization of the surgical field.

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The NEW DOUBLO 2.0 with RM and RM(B) handpiece is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
The NEW DOUBLO 2.0 with PS handpiece is intended for the removal and destruction of skin lesions and coagulation of tissue.

This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, three handpieces, foot switch, LCD touchscreen and power cable.

The NEW DOUBLO 2.0 has three handpieces:

The device is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis with RM and RM(B) handpieces and the removal and destruction of skin lesions and coagulation of tissue with PS handpiece.

The device is intended for use by trained healthcare professionals in a clinical setting to provide controlled radiofrequency therapy through non-invasive procedure.

RF uses electromagnetic wave frequencies to generate an electric field within tissue to cause heating. The amount of energy delivered to tissue is proportional to the current, time, and resistance within the tissue, also known as impedance. Tissue impedance is the main variable in the amount of heat delivered by the generated electric current.

High frequency amplification is performed and it is transmitted to the handpiece. The corresponding output is controlled through the Foot Switch and Hand Switches, and when the Foot Switch and Hand Switches are pressed, each handpiece irradiates the transmitted high-frequency energy to the skin.

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Bipolar applicator CelonProBreath is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar Radiofrequency Induced Thermotherapy (RFITT).

Bipolar applicator CelonProBreath is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically:

• Shrinkage of submucosal tissue in nasal airway obstruction by reduction of hypertrophic nasal turbinates.

The product is intended to be used for patients from 2 years and up.

Bipolar applicator CelonProSleep plus is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar radiofrequency induced thermotherapy (RFITT).

Bipolar applicator CelonProSleep plus is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically:

• Shrinkage of submucosal tissue and tissue coagulation in the soft palate for the treatment of snoring.

The product is intended to be used for patients from 18 years up.

The devices subject to this submission are sterile, single-use devices: the bipolar applicator CelonProBreath (WB990210 and WB990310) and the bipolar applicator CelonProSleep plus (WB990211 and WB990311). The devices are for use with a compatible electrosurgical generator. This method of treatment is also called bipolar radiofrequency induced thermotherapy (RFITT). The devices are intended for the ablation and coagulation of soft tissue in otorhinolaryngeal surgery.

Bipolar applicator CelonProBreath (WB990210 and WB990310) is specifically used for shrinkage of submucosal tissue in nasal airway obstruction by reduction of hypertrophic nasal turbinates.

Bipolar applicator CelonProSleep plus (WB990211 and WB990311) is specifically used for shrinkage of submucosal tissue and tissue coagulation in the soft palate for the treatment of snoring.

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