Novoxel® is committed to Quality and to consistently maintain the level of operations required to meet customer requirements.
Novoxel® is certified and operates under a Quality Management system which complies with the requirements of ISO 13485:2016 for design, manufacture and customer support of our fractional thermo-mechanical resurfacing devices.  
 

Regulation
Novoxel® is regulated and certified under the Medical Device Regulation, EU Quality Management System Certificate- MDR 725869 
Novoxel® family of products comply with additional local regulations in the countries where they are marketed.
 

COUNTERFEIT DEVICES – A WARNING

We are aware of the availability of counterfeit Tixel® devices via online and offline channels. These devices are suspect of not being biocompatible, and as such, are potentially unsafe, harmful and may cause irreparable tissue damage. Please beware of counterfeits, which may lead to serious health and safety issues. Buying, selling, or being in possession of counterfeit products is illegal.

Novoxel’s devices comply with strict regulatory tests. Contrary to Novoxel’s devices, counterfeit Tixel® devices do not undergo any regulatory inspection and the use thereof can expose a patient to danger, including severe burning and permanent scarring.

Novoxel’s devices are distributed by Novoxel’s licensed distributers and are not available for sale through online popular e-commerce platforms. If you encounter a counterfeit suspect (either purchased or offered) or have doubts regarding its genuineness, please contact us without delay at [email protected].

Your clients are your most valuable asset – keep them safe.