Eclipse Micro Pen Eclipse PRP Eclipse Skinfinity RF
Call Toll Free 1-800-759-6876 CONTACT US

NEWA_Safety_081816

 

Intended Use

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.

 

Contraindications

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.)

 

Warnings

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:

  • Are pregnant or breastfeeding. (Safety and effectiveness of the device was not tested.)
  • Suffer from autoimmune disorders or diabetes. (The skin healing in these cases may be impaired.)
  • Have any lesions on the treatment area.
  • Have blood-clotting disorders .
  • Use blood-thinning medications. (The mechanical massage by the device may induce skin hematoma.)
  • Are using or have used Isotretinoin (Accutane) within the past 6 months. (When using Isotretinoin, the skin is more fragile than usual and may be easily injured by any mechanical massage.)
  • Have severe, deep wrinkles.
  • Use in subjects without total removal of facial hair may result in follicular burn in these areas.

Since effectiveness of the device was not tested on individuals with the following conditions, the effectiveness of the device is unknown if you:

  • Have moderate wrinkles under the chin.
  • Are younger than 37 years old.

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.)

 

NEWA Approved By

Eclipse Aesthetics

5916 Stone Creek Dr. Suite #120
The Colony, TX 75056
United States

Call or fax us

Toll-free: 1-800-759-6876
Local: 1-972-380-2911
Fax: 1-866-558-0415

drop us a line

sales@eclipsemed.com

ECLIPSE THE COMPETITION © Eclipse Aesthetics, All rights reserved