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.

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4 Comments
  1. kelley says:

    Hi, I dont understand the difference between zgts titanium and zgts disposable derma roller. Are they the same product or differnt?

    19th May 2009 at 5:09 pm

  2. Amy says:

    Hi! The ZGTS Titanium has stronger needles than the disposable, so the needles are less likely to bend out of shape. Although the needles on these tend to be a little bit thicker than those of a disposable, they are best used on areas such as the thighs and stomach which have slightly thicker skin. These rollers are great for stretch mark and cellulite treatment.

    19th May 2009 at 3:49 pm

  3. Sarah S. says:

    Hello,

    I’m planning to buy from amazon a derma roller to help remove or at least improve the appearance of my stretch marks. My question to you is :” Which brand would you recommend and how long should the needle be ?” . Also, I appreciate this website’s honesty in telling their customers the honest truth about brands that claim they are FDA approved when in reality they aren’t at ALL. I would also like to ask you: ” if I buy a derma roller from amazon and use it on my body will it harm me in any way?” (I’m asking this very important Question because with derma roller we (the customers) are using needles on our skin and there is also blood involved) Which begs the question, “Am I harming myself when using such a product??”, as well as thinking, ” Will this cause any infections because needles and blood are involved??”

    Thank you for your time and please reply as soon as you read this.

    Thanks,

    Sarah

    t

    19th May 2009 at 4:41 pm

  4. Amy says:

    Hi Sarah,
    I would recommend a brand called Dr Roller for it’s high quality and durability. Exercise caution when buying from Amazon, as it is a site which does not specialize in Derma-rolling and skin care products.

    When rolling blood should not really be drawn, although it has been noted that this can occur. If blood is drawn, we recommend trying a smaller needle size – the needles should lightly prick the skin to trick it into believe it that it needs healing, not damage it. NEVER use a roller that has arrived without its protective packaging and if you choose to reuse it make sure that it is sterilized correctly. This should minimize any rick of infection. You may experience slightly red or tender skin post rolling, but this is a common side effect which does not last long and can be minimized with the use of a good moisturizer.

    Happy Rolling!

    19th May 2009 at 9:37 am

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