Can our serums be used with a cryo-device?
Every claim with regard reduction and elimination (destruction) of fat cells is no longer considered as a cosmetic application and belongs so under medical practices.  (MDR 2017/745/EU legislation instead of Cosmetic EC 1223/2009). Â
If you like you may consult the EC MDR legislation 2017/745/EU where you can find in ANNEX XVI : LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEICAL PURPOSE REFERRED TO IN ARTICLE (2)Â Â
The subjects named in this ANNEX XVI are considered as medical device ! Â
(4) Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipo-plasty. Â
In general, I do not see why a cream would be used prior to work with the device.  The temperatures needed for adipocyte freezing are between -8 and -12°C.  As our cream is containing all together about 48% of water it might not be a good idea.  I rather would use it than after the treatment.
But, how about that we claim to increase Lipolysis, both with NBE device and serum? Do we need to re-adjust anything in our texts?
The big difference is that they destroy the fat cell. The cells go in apoptosis which means that they are destroyed. Â
We promote lipolysis. This means we promote the natural way that a fat cell burns fat to energy which is the same when you do sport training. Â
However, you are right, we should try to avoid the use of the word lipolysis and start to promote body contouring or sculpting.
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