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

FAQ Standards

Is the 4D-Sculpt CE marked?

Yes, it is CE marked and built in ISO 9001 and ISO 13485:2016 certified facilities according to ISO certified processes.

Is the 4D-Sculpt itself FDA approved?

We have not undertaken the extremely expensive and time consuming process of FDA approval for the 4D-Sculpt 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 Vacuum Targeted RF Body Sculpting approach implemented within the 4D-Sculpt has been generally FDA approved for cellulite reduction.

Have you performed clinical trials?

The 4D-Sculpt 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 4D-Sculpt.  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 4D-Sculpt 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 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.

Is the 4D-Sculpt "Medical Grade"

In short, “yes”!

Safety and quality are paramount in the inch loss and aesthetics industry, and the new, medical grade PureGenex 4D-Sculpt delivers!  Being ISO 13485:2016 certified, the facility is involved in the design, production, installation and servicing of medical devices and related services.  In order to meet this highly regulated standard, this state of the art facility must be able to demonstrate high quality management processes and ensure best practice in everything we do.  So, when looking for the best Cavitation and Radio Frequency Machine, look no further than the new 4D-Sculpt.