Tixel® Receives FDA 510(k) Clearance
510(k) Clearance
Novoxel announces that Tixel® has received 510(k) clearance for dermatological procedures requiring ablation and resurfacing of the skin.
Press Release – Novoxel Ltd. – Netanya, Israel | Feb 28, 2021
Novoxel, the manufacturer of the Tixel® and Mezotix® products announced that its first generation product, Tixel® has received 510(k) clearance for dermatological procedures requiring ablation and resurfacing of the skin.
"To get the first 510K clearance for Tixel® was one of our primary goals. This achievement is the result of hard work by Novoxel employees assisted by our worldwide key opinion leaders. We're very grateful that we can now offer this product to physicians in the United States. Since launching of Tixel® in Europe and many other countries several years ago, we have seen a growing demand from physicians and patients for our unique products."
— Mr. Evgeny Piven, CEO of Novoxel
"Tixel products are registered and marketed in over 30 countries which are continuously contributing to our clinical experience. Over twenty research papers based on clinical studies have been published in leading peer-reviewed journals. Novoxel is focused on continuing its clinical research, product development and expansion of our product portfolio and indications."
— Mr. Raphi Shavit, Chairman
About Novoxel
Novoxel® is an Israeli company with headquarters in Netanya, Israel and subsidiary companies in Berlin, Germany and Tokyo, Japan. The Company was founded in 2011 with a vision to introduce a significant contribution to fractional aesthetic skin treatments.
Our proprietary TMA® technology is a game-changer: a patient and user friendly technology for fractional skin resurfacing which transfers heat directly and efficiently to tissue without emitting radiation.
Contact
Mr. Evgeny Piven, CEO evgeny@novoxel.com