Search Results

The Legend X Platform 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 the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar radiofrequency (RF) Energy and for transcutaneous electrical stimulation of periorbital, facial, and body muscles with DMSt (Dynamic Muscle Stimulation technology) for aesthetic purposes, including improvement of appearance, and for body muscle conditioning to stimulate healthy muscles. (Applicators 1-3).

The Legend X Platform ("Proposed Device") is a software-controlled capital equipment platform that enables application of radiofrequency (RF) energy onto the skin for ablation, resurfacing, or noninvasive treatment of wrinkles and rhytides or electrical stimulation of skin and muscles throughout the face and body. The application of RF or dynamic muscle stimulation 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 of the Foot Switch and Applicators.

The proposed device consists of a Console with connected Foot Switch, Patient Controlled Manual Switch, Applicators, and Applicator accessories (disposable tips) needed to perform some of Legend X dermatological and general surgical procedures. The summary descriptions of each component are outlined below.

Legend X Console: The Legend X 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 software. The monitor allows for user input during initial setup and throughout the session. The console also provides power and connectivity for the applicators, foot switch, and patient manual-controlled switch.

Legend X Foot Switch: The Legend X Foot Switch (Foot Switch) is connected to the Legend X Console via a connector cord. The Foot Switch enables or disables the energy delivery through the applicators to treatment area.

Legend X Applicators: The Legend X Applicators (1, 2, 3 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 of wrinkles and rhytides onto the skin throughout the face and body. Each applicator is connected to the Console via an Applicator Connector cord.

Legend X Patient Controlled Manual Switch: The Legend X Patient Controlled Manual Switch is also a handheld device that serves as the patient interface that allows the patient to stop the operation of the chosen treatment mode upon the press of a button. In this situation, the system does not allow operation to continue. A Patient Controlled Manual Switch cord connects the Patient Controlled Manual Switch to the Console. 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 Applicators on the skin or muscle area of interest throughout the face and body. It receives user input from the Legend X Console, Foot Switch, and Patient Manual Controlled Switch, and computes the appropriate output to 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 Disposable Tips: The Legend X Disposable Tips set is part of the Legend X Platform accessories kit. The Disposable Tips Set includes:

• gen12 disposable tip
• gen 36 disposable tip
• gen 36L disposable tip
• gen 100 disposable tip
• 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 radiofrequency electrical current via an array of multi-electrode pins onto the skin surface.

N/A

Ask a specific question about this device