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

FAQ Standards

Is the ProSculpt CE marked?

Are Velashape, Thermage, Lipo Angel, 3d-lipo and PureSculpt the same treatmentYes, it is CE marked and built in ISO 9001 certified facilities according to ISO certified processes.

Is the ProSculpt itself FDA approved?

We have not undertaken the extremely expensive and time consuming process of FDA approval for the ProScult 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 Body Sculpting approach implemented within the ProSculpt has been generally FDA approved for cellulite reduction.

Have you performed clinical trials?

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

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 ProSculpt. 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 ProSculpt platform and treatment approach in the real world, where real results count!

Where is the device manufactured and tested?

Can the ProSculpt perform the Brazilian Bum Lift TreatmentMuch 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 Hong Kong, China), with primary build processes taking place in Hong Kong 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.