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Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region. The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical (specifically BVX-200H, BVX-200P, APYX-200H, APYX-200P, APYX-RS3, and APYX-JS3).

The Renuvion® APR Handpiece is a sterile, single-use electrosurgical (monopolar) device intended to be used in conjunction with compatible electrosurgical generators. The compatible generators operate at an adjustable power of up to 40W (expressed as 0-100% where 100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas passes over the energized electrode, a helium plasma is generated for soft tissue cutting, coaqulation or ablation. The Renuvion® APR Handpiece has a non-extendable electrode to generate helium plasma. The handpiece is available in two different lengths: 15cm and 27cm. The 15cm length is available in a single port (APYX-15-SP) as well as a twin port configuration (APYX-15-TP). The 27cm length is only available with a twin port configuration (APYX-27-TP).

The Renuvion® Dermal System is an electrosurgical device for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III. The treatment is achieved through controlled heating of the outer layers of the skin so that part or all of the epidermis becomes non-viable and there is controlled thermal modification to the underlying dermis. The Renuvion® Dermal Handpiece is only compatible with Apyx Medical Electrosurgical Generators.

The Renuvion® Dermal Handpiece is a sterile single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible Apyx Helium Plasma Generator (APYX-200P, APYX-RS3 - cleared under 510(k) K170188 & K192867) for the delivery of radiofrequency energy and/or helium plasma for the delivery of helium plasma for the noninvasive treatment of facial wrinkles and rhytides, in patients with Fitzpatrick skin types I, II or III. The Renuvion Dermal handpiece is part of the Renuvion System composed of the compatible Apyx generator, Foot switch, helium source, and patient grounding pad. The tip of the Renuvion® Dermal Handpiece is used to deliver thermal energy to tissue through a precise helium plasma beam. The device connects to the electrosurgical generator which is also connected to a helium gas tank and regulator. The device requires the use of a grounding pad plugged into the generator to complete the circuit. The device is offered only in one size, 44mm, catalog number APYX-044-DERM. The handpiece is activated by pressing the activation button on the handpiece or by pressing the purple foot pedal on the foot control accessory. The device is rated at 4.0kVpeak.

The J-Plasma Precise® FLEX is used for the delivery of radiofrequency energy and/or helium gas plasma (J-Plasma energy) for electrosurgical cutting, coagulation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures. The J-Plasma Precise® FLEX is compatible with Apyx Medical electrosurgical generators.

The J-Plasma Precise® Flex Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the delivery of radiofrequency ("RF") energy and/or helium gas plasma for electrosurgical cutting, coaqulation, and ablation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures. The handpiece has one configuration, model # APYX-500BF. The compatible Generators operate at an adjustable power of up to 40 W (expressed as 0-100% where 100% is 40 W) and provide an adjustable helium gas flow of 1-5 LPM. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The J-Plasma Precise® Flex Handpiece has an extendable electrode (blade) in the tip to generate helium plasma. The tip is controlled by the user via graspers to actuate (extend and retract) the blade. The handpiece comes with an Introducer that allows for more control of the tip when introducing and removing the distal end to and from the cannula. The handpiece has a flexible, seamless cable that can be advanced with graspers through the cannula during minimally invasive surgical procedures. The handpiece is activated by the footswitch.

The Apyx Helium Plasma Generators (owned by Apyx Medical) are indicated for delivery of radiofrequency energy and/ or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The helium plasma portion of the generator can be used only with dedicated Renuvion/ J-Plasma handpieces.

The Apyx Helium Plasma Generator is an electrosurqical device that delivers radiofrequency (RF) energy to cut and coaqulate soft tissue. It can also deliver Helium plasma energy for cutting, coagulation, and ablation of soft tissue. Like the predicate, the Apyx Helium Plasma Generator provides standard electrosurgical energy and Helium Plasma energy, and there are no changes to the intended use, performance specifications, electrosurgical modes, output power waveforms or maximum power settings. Essentially, the Apyx Helium Plasma Generator is a combination of a standard electrosurgical generator and a Helium Plasma generator.

The Apyx Plasma/RF Handpiece is intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation of soft tissue during open surgical procedures. The Apyx Plasma/RF Handpiece is compatible with the Electrosurgical Generators, BVX-200H and BVX-200P, owned by Apyx Medical.

The Apyx Plasma/RF Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. The compatible Generators operate at an adjustable power of up to 40W (expressed as 0-100% where 100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Apyx Plasma/RF Handpiece has a non-extendable electrode to generate helium plasma. The handpiece is available in two different lengths: 15cm and 27cm. The 15cm length is available in a single port (APYX-15-SP) as well as a twin port configuration (APYX-15-TP). The 27cm length is only available with a twin port configuration (APYX-27-TP).

The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible electrosurgical generators for the delivery of helium plasma for cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures. The Renuvion®/J-Plasma® Precise Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P manufactured by Apyx Medical.

The Renuvion®/J-Plasma® Precise Handpiece is a sterile, single use electrosurgical accessory intended to be used in conjunction with compatible electrosurgical generators for the delivery of helium gas plasma for cutting, coagulating, and ablating soft tissue. The compatible Generators operate at an adjustable power of up to 40W (expressed as 0-100% where 100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. The Renuvion/J-Plasma Precise Handpiece is available with a retractable cutting tip blade for excising tissue. The blade tip serves as an electrode to generate helium plasma. The blade can be extended in 2mm increments from 0 to 10mm from the distal tip of the shaft via a ratcheted slider and retracted via a release latch. The device is activated via pressing the purple activation trigger. The handpiece is to be used with compatible electrosurgical generators, BVX-200H or BVX-200P, manufactured by Apyx Medical. The Renuvion®/J-Plasma® Precise Handpiece is available in a 33 cm length for use in laparoscopic or open surgical procedures. The 33 cm is a standard length for laparoscopic instruments and are compatible with standard 5 mm trocars.

The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible J-Plasma electrosurgical generators for the delivery of helium plasma for cutting, coagulation of soft tissue during open and laparoscopic surgical procedures. The Renuvion®/J-Plasma® Precise Open Handpiece is intended to be used with compatible J-Plasma electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion®/J-Plasma® Precise Open® Handpieces are compatible with electrosurgical Generators BVX-200H, and BVX-200P.

The Renuvion/J-Plasma Handpieces are sterile, single use electrosurgical accessories intended to be used in conjunction with compatible electrosurgical generators for the delivery of helium gas plasma for cutting, coagulating soft tissue. The compatible Generators operate at an adjustable power of up to 40W (expressed as 0-100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. The Renuvion/J-Plasma Handpieces are available with a retractable cutting blade tip for excising tissue. The blade tip serves as an electrode to generate helium plasma. The Renuvion/J-Plasma Precise devices are available in 15cm, 27cm and 33cm lengths for use in laparoscopic or open surgical procedures. The 27cm are standard lengths for laparoscopic instruments and are compatible with standard 5mm trocars. The Renuvion/J-Plasma Precise Open devices are available in 44mm and 150mm for used in open surgical procedures.

The Bovie J-Plasma Precise Flex Handpiece is used for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures. The Bovie J-Plasma Precise Flex Handpiece is compatible with Bovie Ultimate Electrosurgical Generators BVX-200H, and BVX-200P.

The Bovie J-Plasma Precise Flex handpiece, is an electrosurgical accessory that is connected to a Bovie Ultimate Electrosurgical Generator and used to deliver helium gas plasma (J-Plasma) and standard electrosurgical monopolar coagulation during surgical procedures. The accessory has a flexible shaft that can be advanced through a cannula during minimally invasive surgical procedures. The handpiece is activated by the generator footswitch. The primary difference between the Bovie J-Plasma Precise Flex handpiece and currently available Bovie J-Plasma handpieces is that the Bovie J-Plasma Precise Flex handpiece has a flexible shaft that can be controlled with graspers, forceps, or grasping instruments during minimally invasive surgical procedures. The Bovie J-Plasma Precise Flex handpiece uses the same basic technology and delivers the same J-Plasma helium plasma energy as currently available J-Plasma handpieces (K151325, K152570, K170188) and are compatible only with Bovie Ultimate electrosurgical generators.

The Bovie Ultimate® Electrosurgical Generators are indicated for delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparascopic surgical procedures. The J-plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces. The Bovie J-Plasma Precise Open® Handpiece is intended to be used in conjunction with the Bovie Ultimate® electrosurgical generator for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. The Bovie J-Plasma Precise Open® Handpiece is compatible with Bovie Ultimate® Electrosurgical Generators BVX-200H, and BVX-200P.

Bovie Ultimate® Gen 2 Electrosurgical Generator is a multipurpose electrosurgical device that delivers high frequency electrical energy to cut and coagulate soft tissue. It can also deliver Helium gas plasma energy (J-Plasma) for the cutting, coagulation, and ablation of soft tissue. The Ultimate Gen 2 electrosurgical generator is the next generation of the original Bovie Ultimate®. The Ultimate Gen 2 has offers the same electrosurgical modes and has the same performance specifications as the original Bovie Ultimate, but the Ultimate Gen 2 will be compatible with the new Bovie J-Plasma Precise Open handpiece passive accessory. The Bovie J-Plasma Precise Open Handpiece is a sterile, single use electrosurgical accessory intended to be used in conjunction with the Bovie Ultimate Gen 2 electrosurgical generator for the delivery of radiofrequency energy and/or a helium plasma gas for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. The handpiece utilizes a retractable blade or needle electrode to ignite the helium gas to create the plasma.

This device is intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. This device is intended to be used with a standard electrosurgical generator with footswitch control and a standard return electrode connection, and the electrode is to be activated only when immersed in a conductive media such as standard saline solution.

The device is comprised of the following major components: an insulated handle, an active electrode, a length of aspiration tubing, a standard foot-switch RF connector, and a standard return connector. The hand piece is designed to connect to electrosurgical generators that feature a standard foot switch controlled monopolar connector and a standard return connector. A stainless steel electrode tip is surrounded by a ceramic thermal insulator. The product is available in shaft diameters of 3.3mm, 2.4mm, and 1.8mm. The larger size is available in aspirating and non-aspirating version. The aspirating versions use suction to remove saline irrigant during the surgical procedure for the dissipation of heat and improved vision. The device is available in electrode face angles of 55 degrees, and 90 degrees. There is a feature on the handle that lets the operator easily determine the orientation of the active electrode face. The wedge-shaped tapered tip allows access to difficult to reach locations. The working length is 160mm. The cable from the handle is 126" +/- 6" in length. The device operates in bipolar mode. The return electrode is located on the device and does not require the use of an external grounding pad or return electrode. The device has a simple user interface that uses a footswitch to activate the device.