I'm not a doc :-)
We see these rollers again and again - they are the same rollers that failed to make it through our test, you can compare them with the description and picture. These rollers are sold in bulk in China for approx. 5 dollars each, when buying a few hundred.
Their FDA entry says that their roller has no FDA registration/permission, look at the actual data:
Submission Type 510(K) Exempt
So their device needs no FDA registration and has no FDA permission because they don't need it. We have been saying that all along - Dermarollers with the needle lengths we sell are not medical devices so no FDA registration is required, and those who claim FDA registration have only an "exempt" number, not a FDA test & approval number. In any case, even a FDA "test" number only means that they believe the manufacturer's own tests. The FDA really doesn't care about safety - they're in the business of making money for Big Pharma first, and making money for themselves second. Safety never enters their equations.
Anyone can submit their company address to the FDA and get a database entry, and anyone can submit any random device and get a "FDA approval not required" number for that device. The FDA gladly sells meaningless "exempt numbers" like that - for a steep fee - but it will of course help you sell more devices because the general public does not understand very much how the FDA works (or how patents or trademarks work, for that matter).
You could use the rollers but I wouldn't recommend it, since they really are the worst rollers available on the market today. If they have not improved since we last tested that type, their handles are too weak to be able to apply steady pressure. It could be that they have changed their needle quality - we found it lacking last time.
Just do not buy into the hype. A roller that's more expensive than 40 dollars is a ripoff. A dermaroller is an exceedingly simple device, originally intended to be thrown away after single use. All rollers on the consumer market are designed and produced with that original design goal in mind - meaning they should be cheap above all - because the whole idea behind them is that they are disposable.
We can safely re-use them when we only use them on ourselves and check the needles before each session and sterilize the roller after each use, but that is not how the inventors of the dermarollers and developers of the "pirated" rollers intended things. All current plastic rollers are still designed with the idea that they will be thrown away after a single use - so they should be cheap.
That's why we think it's outrageous that anyone dares to ask so much money for a roller. And the craziest aspect about such price gouging is that they always do it with the cheapest, worst rollers.
Topic: Is it safe to use Clinical resolution dermaroller on my damaged skin? (Read 10103 times)
