Is the CryoGen CE marked?
Yes, it is CE marked and built in ISO 9001 certified facilities according to ISO certified processes.
Is the CryoGen itself FDA approved?
The CryoGen 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 and CryoGen. 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 CryoGen 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. Mitsubishi Laser Diodes from Japan, connectors from Germany, Screens from Japan, PCBs and cases from 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.
