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

FAQ Standards

Is the PureCryo CE marked?

Is PureCryo the best fat freezing machineYes, it is CE marked and built in ISO 9001 certified facilities according to ISO certified processes.

Is the PureCryo itself FDA approved?

We have not undertaken the extremely expensive and time consuming process of FDA approval for the PureCryo platform itself, as we do not market our machines in the United States, where FDA approval is applicable. This enables us to avoid incurring this significant cost, ensuring these costs are not passed onto our customers.

However, the Cryogenic Lipolysis approach implemented within the PureCryo has been generally FDA approved for spot fat reduction.

Have you performed clinical trials?

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

Cryogenic Lipolysis techniques were developed and proven by Physicians Dieter Manstein, MD, PhD and R. Rox Anderson, MD at The Wellman Center at Massachusetts General Hospital (part of the Harvard Medical School). There have been several clinical trials and comparative studies performed since to optimise the treatment protocols.

Any claims we state are based upon results achieved during real-world treatments performed by our head trainer and other clinics that have purchased the PureCryo. 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 PureCryo platform and treatment approach in the real world, where real results count!

Where is the device manufactured and tested?

Is PureCryo fat freezing the same as coolsculpting and lipoglazeMuch 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.