The EndyMed NEWA® is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult men and women of all skin types.
DO NOT USE THE NEWA® IF YOU HAVE ANY OF THE FOLLOWING:
An implanted pacemaker, arrhythmias or any other severe known heart disorder. (The flow of electrical energy through the body may damage the pacemaker and cause dangerous heart arrhythmias.)
Since safety and effectiveness of the device was not tested on individuals with the following conditions, it is NOT advised that you use the device if you:
Since effectiveness of the device was not tested on individuals with the following conditions, the effectiveness of the device is unknown if you:
Do not use the NEWA® over the eyebrows, eyelids, lips, ears, breasts or genital area. Eye damage, damage to glands, sensitive and delicate skin and other tissue may occur. Follow instruction for use as directed for your safety.
Patients with visual difficulties should not use this device.
You should not use the NEWA® if you have any implantable metal device or body piercing in the treatment area. (The flow of electrical energy through the implanted metal may heat the object and cause burns.)