Dermarollers Approved by the FDA

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Posted on 19th May 2009 by admin in Dermaroller Facts

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Question: I see that not all the Dermarollers you sell are FDA approved. Can you tell me which Dermarollers are FDA approved?

We have gone to great lengths to confirm the FDA status of all Dermarollers. After consulting the FDA and finding no record of any dermaroller establishing FDA approval we have established that the following is correct.

In the USA, “roller”-type devices, when not making therapeutic claims, are classified as Class I medical devices (Manual Surgical Instruments for General Use) under 21 CFR 878.4800. This is the classification being used by the manufacturers and the basis upon which they are available in the USA. If therapeutic claims are made, either clearance of a 510(k) premarket notification or approval of a premarket approval application (PMA) is required.

As is the case with all medical devices, manufacturers of Class I devices under 21 CFR 878.4800 are required to register their establishment and list their devices. A registration number and owner/operator number is obtained, but this is purely an administrative process

Our job at Dermaroller Planet is to give you unbiased, open and honest information on all of our products. Baring this in mind, and failing any further contact directly from the FDA, Dermaroller Planet has taken the correct position that no Dermaroller has FDA approval.

This of course does not alter the fact that micro-needling is a wholly safe process. As responsible retailers, it is imperative we give you the full facts and we are confident that as responsible retailers, we should not misleadĀ  any of our customers in any way. Our responsibilities lie with the customer, not the manufacturer!

Should you come across any dermaroller products being sold with FDA approval from any site, please be aware that not all companies take the same moral standpoint and will continue to brand identical products to ours with full FDA approval.

If you have any questions, please do not hesitate to ask. You can leave comments below which will be answered by a member of our team or contact us directly at lookinggood@dermaroller-planet.com

Answer: No Dermarollers on the market, have FDA approval and claims of such should be viewed with the utmost caution. Whilst they are registered with the FDA, this is an administrative process and does not mean approval has been obtained.