Novoxel™ is committed to Quality and to consistently maintain the level of operations required to meet customer requirements.
Novoxel™ is certified and operates a Quality Management system which complies with the requirements of ISO 13485:2016 for design
manufacture and customer support of thermo- mechanical ablation systems in dermatology.
Novoxel™ is regulated and certified under EC Certificate- CE643960, Full Quality Assurance System Directive 93/42/EEC on medical
Devices, Annex II excluding section 4.
Novoxel™ family of products comply with additional local regulations in the countries where they are marketed.
• ISO 13485:2016 for design manufacture and customer support of thermo- mechanical ablation systems in dermatology.
• EC Certificate according to the medical Device directive
• Australia: Therapeutic Goods (medical Devices) Regulations, 2002, Schedule 3 Part 1(excluding Part 1.6) – Full Quality Assurance
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 have exceeded the strictest regulatory standard 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.
|KORAKH & Co. REF.||TERRITORY||PATENT NUMBER||TITLE|
|005396US||USA||US 9,402,678 B2||TITLE METHODS AND DEVICES FOR TISSUE ABLATION|
|005396USD||USA||US 10,327,832 B2||METHODS AND DEVICES FOR TISSUE ABLATION|
|005396EP||European Union||EP 2 459 092 B1||DEVICE FOR TISSUE VAPORIZATION|
|005396IL||Israel||217734||METHODS AND DEVICES FOR TISSUE ABLATION|
|005396JP||Japan||P5774001||METHODS AND DEVICES FOR TISSUE ABLATION|
|005397CN||China||ZL 2014 8 0074496.5||DEVICES AND METHODS FOR TISSUE VAPORIZATION|
|005399CN||China||ZL 2015 8 0061055.6||METHODS AND DEVICES FOR THERMAL TISSUE VAPORIZATION AND COMPRESSION|