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
|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|