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The Legend X Desktop System and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO). It is also intended for use in dermatologic and general surgical procedures for non-invasive treatment when using RF Energy and for muscle conditioning to stimulate healthy muscles (TriPollar Applicator). Legend X Desktop System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. Legend X Desktop System is intended to be operated by a licensed health care practitioner who is present to monitor treatment.

The Legend X Desktop System ("Proposed Device") is a software-controlled capital equipment system that enables application of radiofrequency energy onto the skin for ablation, resurfacing, or noninvasive treatment or muscle activation pulses. The application of radiofrequency energy or muscle activation pulses only occurs under the continuous and direct control of a user with direct visualization, via the user inputs into the console, applicator indicators and subsequent operation. The proposed device consists of a console with connected applicators, and applicator accessories (disposable tips) needed to perform some of Legend X Desktop dermatological and general surgical procedures. The summary descriptions of each component are outlined below. Legend X Desktop Console: The Legend X Desktop Console (also known as the Console or Main Control Unit) contains the graphic display interface for the user that is provided by a touchscreen monitor for viewing and a computer running the Legend X Desktop software. The monitor allows for user input during initial setup and throughout the session. The console also provides power and connectivity for the applicators. Legend X Desktop Applicators: The Legend X Desktop Applicators (TriPollar and VO) are handheld handpieces which deliver energy to the treatments area. Depending on the applicator and selected user inputs, the user can utilize the applicators to deliver either muscle energy onto the muscles of the face and body or RF energy for ablation and resurfacing or noninvasive treatment onto the skin. Each applicator is connected to the console via an applicator connector cord. Legend X Desktop Software: The Legend X Desktop software provides the user and patient with the ability to safely commence, drive, and stop the operation of the applicators on the skin or muscle area of interest throughout the face and body. It receives user input from the subject console to compute the appropriate output via the chosen applicator connected to the console. It provides a graphical user interface where the treatment timeline as well as status of operation is shown in real time and displays important system status information. Legend X Desktop Disposable Tip Accessories: The Legend X Desktop disposable tips set is part of the Legend X Desktop Applicator VO kit. The Disposable Tips Set includes: - . gen12 disposable tip, - gen36 disposable tip, - . gen36L disposable tip, - gen100 disposable tip, and - H7X7 disposable tip The patient contacting portions of the disposable tips are constructed of stainless steel and gold plating. The disposable tips are connected to handheld Applicator VO for delivery of RF energy via an array of multi-electrode pins onto the skin surface.

The Legend X Applicator VO and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (tips gen12, gen100, gen 36, gen36L, H7x7). The Legend X Applicator VO with genXL tip is intended for use in dermatological procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use of the Applicator VO with genXL tip is limited to Skin Types I-IV.

The Legend X Applicator VO ("Proposed Device") is connected to the Legend X softwarecontrolled capital equipment platform to enable application of radiofrequency onto the skin for ablation and resurfacing or electrocoagulation and hemostasis. The proposed device applicator and applicator accessories are identical to the recently cleared Legend X Platform (K232903), with the exception of the new optional Applicator VO genXL disposable tip. The application of radiofrequency with the Applicator VO Disposable Tip only occurs under the continuous and direct control of a user with direct visualization, via the user inputs into the Legend X Console and Applicator indicators. The proposed device consists of applicators and applicator accessories (disposable tips) needed to perform some of Legend X dermatological procedures. The summary descriptions of the proposed device are outlined below. Legend X Applicator VO: The Legend X Applicator VO is a handheld handpiece which delivers energy to the treatment area. Depending on the selected user inputs, the user can utilize the applicator to deliver fractional RF energy for ablation and resurfacing, or electrocoagulation and hemostasis, as a means for noninvasive skin treatment throughout the face and body. The Applicator VO is connected to the cleared Legend X Console via an Applicator Connector cord. Legend X Software: The Legend X Software provides the user and patient with the ability to safely commence, drive, and stop the operation of the Applicator on the skin area of interest throughout the face and body. It receives user input from the Legend X Console and computes the appropriate output to the Applicator VO connected to the Console. It provides a graphical user interface where the treatment parameters are adjusted as well as status of operation is shown in real time and displays important system status information. Legend X Applicator VO Disposable Tips: The Legend X Applicator VO Disposable Tips set is part of the Legend X Applicator VO kit. The Legend X Applicator VO Disposable Tips Set includes: - 1. gen12 disposable tip - 2. gen36 disposable tip - 3. gen36L disposable tip - 4. gen100 disposable tip - 5. H7X7 disposable tip - 6. genXL disposable tip The patient-contacting portions of the disposable tips are constructed of stainless steel and gold plating. The disposable tips are connected to handheld Applicator VO for delivery of radiofrequency electrical current via an array of micro-electrode pins onto the skin surface.

The GENEO X ELITE system with the TriPollar RF Applicator is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV. The GENEO X ELITE system with the OxyGeneo Applicator is intended to provide massage by a mechanical vibration of an electrically powered applicator. The OxyGeneo treatment is suitable for all skin types.

The GENEO X ELITE device is a non-invasive, tabletop console with a graphical user interface (GUI), which supports two applicator types: the TriPollar Radiofrequency (RF) Applicator utilizing bipolar radiofrequency technology for facial wrinkles treatments and the OxyGeneo Applicator utilizing mechanical vibration for facial massage sensation. The GENEO X ELITE device is manufactured by Pollogen Ltd. Similar to the predicate device, the STOP U Model UXV device, the GENEO X ELITE device constitutes the same underlying TriPollar technology to employ bipolar RF energy in a non-invasive manner utilizing the TriPollar RF Applicator. In addition to the TriPollar RF applicator the GENEO X ELITE device comprises the OxyGeneo Applicator. The OxyGeneo Applicator is an electrically powered massager utilizing mechanical vibration generated by an electrically powered motor housed in the applicator.

The STOP U Model UXV device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV.

The STOP U Model UXV device delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The device consists of the following components and accessories: The STOP U Model UXV device (applicator unit), the STOP U Model UXV Power Supply and the STOP Preparation Gel.

The YandR System is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Handpiece.

The YandR System, subject of this submission as well as the cleared systems of the Legend Pro RF Family of Systems (Pollogen Legend+ system (listed as Legend Pro); see K122200, K131758, K171359 and K173503) are computer-controlled RF devices connected to a treatment Handpiece/Applicators and disposable tips. The system is comprised of: - System Console - . VoluDerm Handpiece/Applicator and single-use sterile removable tips (present only in the Surgen, Legend Pro and YandR Systems) The YandR System with its VoluDerm Handpiece is a new model of the modified Legend Pro Family of RF Systems The YandR System as the cleared Pollogen Legend+ system can generate a 1MHz sinusoidal signal applied by the VoluDerm Handpiece and the same VoluDerm Tips with bi-polar electrode pins at up to 62 Joules/per pin. The proposed system relies on the same fundamental underlying technology of the cleared systems with some hardware and software modifications to meet the marketing requirements for a more compact and simple device (tabletop console instead of a floor-mounted, rolling console) with a modern interface and the support of only the VoluDerm Handpiece (removing the TriPollar Applicators), similarly to its predecessor, the Pollogen Ltd.'s Surgen U (K131758). Also, to simplify the system, the YandR system has a hand switch, integrated into the VoluDerm Handpiece (called the Handpiece Trigger), instead of a separated Footswitch.

The STOP U Model UXV device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types II-IV.

The STOP U Model UXV device delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The device consists of the following components and accessories: The STOP U Model UXV device (applicator unit), the STOP U Model UXV Power Supply and the STOP Preparation Gel.

The STOP U device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types II-IV.

The STOP U device delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The device consists of the following components and accessories: The STOP U device (applicator unit), the STOP U Power Supply and the STOP Preparation Gel.

The Pollogen Legend+™ System is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO). It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3).

Pollogen Ltd's modified Legend*™ system delivers bipolar radiofrequency (RF) electrical current to the skin surface for dermatological procedures requiring ablation and resurfacing of the skin. The physician can control the parameters of the device through a user interface. The system consists of: - Main Unit (includes the Controller); - - Control Panel (User Interface); - - RF Generator; - - VO (VoluDerm) Treatment Applicator - - Disposable tips; gen12, gen36 & gen36L - - Treatment Applicators 1-3 (TriPollar); - - Foot Switch; - - Patient-Controlled Manual Switch. - The device generates RF energy, which is applied to the skin. The VO (VoluDerm Energy) treatment applicator applies pulses of bipolar RF energy that flows between electrodes to create micro-ablation points on the skin via an array of multi-electrode pins. The TriPollar treatment Applicators 1-3 apply bipolar RF energy that flows between electrodes on the skin. The three applicators differ in size and configuration and are indicated for treatment of various size facial areas. The operator can adjust treatment parameters, such as the power level and treatment time from the user interface on the Main Unit. The Applicator is applied with a little pressure and a rubbing/massaging technique (linear, circular, etc., depending on the area). The applicator should be moved continuously on the skin. No active cooling of the electrodes or the skin is required.

The Pollogen Legend+™ System is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO). It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3).

The Pollogen Legend*™system delivers bipolar radiofrequency (RF) electrical current to the skin surface for dermatological procedures requiring ablation and resurfacing of the skin. The physician can control the parameters of the device through a user interface. The system consists of: - Main Unit (includes the Controller); - - Control Panel (User Interface); - - RF Generator: - - -VO (VoluDerm) Treatment Applicator; - -Treatment Applicators 1-3 (TriPollar); - Foot Switch; - - Patient-Controlled Manual Switch. - The device generates RF energy, which is applied to the skin. The VO (VoluDerm Energy) treatment applicator applies pulses of bipolar RF energy that flows between electrodes to create micro-ablation points on the skin via an array of multi-electrode pins. The TriPollar treatment Applicators 1-3 apply bipolar RF energy that flows between electrodes on the skin. The three applicators differ in size and configuration and are indicated for treatment of various size facial areas. The operator can adjust treatment parameters, such as the power level and treatment time from the user interface on the Main Unit. The Applicator is applied with a little pressure and a rubbing/massaging technique (linear, circular, etc., depending on the area). The applicator should be moved continuously on the skin. No active cooling of the electrodes or the skin is required.