INDICATIONS FOR USE:
The Renuvion® Dermal System is an electrosurgical system 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.
DEVICE DESCRIPTION:
The Renuvion® Dermal Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible, electrosurgical generator by trained and duly qualified medical practitioners for the delivery of helium plasma in dermatological wrinkle reduction. The handpiece is activated by pressing the activation button or by pressing the purple foot pedal on the footswitch accessory. This
device is intended for use by qualified medical personnel trained in the use of energybased systems for the treatment of wrinkles and rhytides. The User should be familiar with the medical literature as well as potential complications and treatment of those complications. It is the responsibility of the User to select appropriate patients, to make a correct diagnosis, to determine the treatment required and determine the post-operative support required for the patient. It is stressed that not following the treatment instructions, warnings, and contraindications in the Renuvion® Dermal System Instructions for Use (IFU) can result in the development of unwanted side effects.
Treatment is achieved through application of controlled heat to the epidermis to selectively damage the skin and prompt a healing response. Similar to other established energy-based systems, the depth of treatment only extends into the upper levels of the dermis to prompt a healing response that stimulates the growth of new
collagen fibers. Biological changes similar to those resulting from other established energy-based wrinkle reduction procedures are produced.
Please note, we are unable to sell this product if you have not had the proper Clinical Training with Apyx Medical.
Price is for case of 6 handpieces.
