PureGenex, Gemini House, 136-140 Old Shoreham Road, Brighton, BN3 7BD sales@puregenex.co.uk

FAQ Standards

Has the PureGenesis been CE marked?

Comparing PureGenesis with i-lipo and Strawberry Laser LipoYes, it is CE marked and built in ISO 9001 certified facilities according to ISO certified processes.

 

Is the PureGenesis FDA Approved?

No, we have not progressed FDA approval.  This is a very costly process and is only required if you intend to market the product in the USA.  Yolo Medical Inc., owns the US patent for the Laser Lipolysis technology in the USA, so there is little point in obtaining FDA approval, as any attempt to market in the USA would infringe that patent!  This is not the case in the UK and EU, as the technology is now considered to be “in the public domain”.

Have you performed clinical trials?

The PureGenesis implements tried and tested technologies, each of which have undergone clinical trials individually.

The originator of the Laser Lipolysis technology (i.e. using diode lasers at a wavelength of 650nm to achieve inch loss) was a Korean company (Meridien), who developed the Lapex BCS.  This was clinically trialed when it was first launched (http://www.lapexbcspro.com/pdf/effects-of-llt-in-subcutaneous-fat-reduction-and-improvement-in-body-contour.pdf ).

All subsequent tests by other manufacturers leveraging the same technology have not been performed as true “clinical trials”, but as comparative studies by individual manufacturers.

Any claims we state are based entirely upon results achieved in combining these technologies to improve on the standard, individual therapies, during real-world treatments performed by our head trainer and other clinics that have purchased the PureGenesis.  We have not performed true clinical trials as this would introduce significant cost (thereby drive up the price paid by the end customer to re-coup such costs) without adding any value beyond the original base technology trials.

In summary, the technology has been proven in clinical trials and we have then proven the PureGenesis platform and treatment approach in the real world, where real results count!

Where is the device manufactured and tested?

Much like most electronic products now (e.g. Apple iPods, iPads, etc.), we design the machines here in the UK, then have components manufactured all around the world (e.g. Laser Diodes from Japan, connectors from Germany, Screens from Japan, PCBs and cases from China), with primary build processes taking place in China and the UK.

All final testing and quality control takes place in the UK prior to delivery, so you can be assured you are receiving a British quality controlled device from a British company.