Are Plasma Pens FDA Approved?

In This Post

1. Basic Information on FDA Approval
2. Are Plasma Pens FDA Approved?
3. Other Certifications Dermavel’s Plasma Pen Has

We all strive to retain our youth, especially when it comes to the appearance of our skin. After all, it’s one of the first things people notice about us. But, looking for the right skin treatments that are both affordable and non-invasive can seem near impossible. Plus, you don’t want to try out something that will require a lot of upkeep and maintenance.

Plasma pens are groundbreaking tools to help people tighten up their skin, lessen the appearance of wrinkles and sagging, and overall promote softer and healthier skin. Not to mention, you’ll probably only need a plasma pen treatment every few years. So you can stop searching for a miracle treatment that will give you the skin you’ve always wanted– the best plasma pens can give you the transformation you’re after.

There are a number of questions that may come to mind when you think about using a plasma pen, like what does the healing process look like, and how quickly will you see results? But, is this all too good to be true? How safe are plasma pens, and are they FDA approved? Let’s take a look below at all the certifications that have been granted to plasma pens, and why you should feel confident in using them.

Basic Information on FDA Approval

So what exactly does it mean to get an FDA approval on a product?

You may have seen certain products or treatments advertised as being FDA approved, which essentially means that the U.S. Food and Drug Administration has deemed a human drug or biological product as safe and effective for the intended use, and that the product is manufactured to federal quality standards. However, it’s important to point out that the FDA doesn’t approve products; rather, they approve the specific uses of a product for certain audiences.

In basic terms, having an FDA approval means that the benefits from using the product outweigh the risks associated with it. In order to achieve an FDA approval, the product must undergo a process involving clinical trials and evaluations to assess the safety and effectiveness of it, which can be quite lengthy. Plus, just because a device or product has achieved an FDA approval doesn’t mean there aren’t risks associated with it either.

So you may still be wondering, what are the plasma pen risks and side effects, and are plasma pens FDA approved?

Are Plasma Pens FDA Approved?

Let’s get right to the point–there aren’t really any plasma pens on the market that are FDA approved. This isn’t to say that plasma pens are unsafe to use, especially when compared to other cosmetic procedures. This newer technology has been proven to be effective and safe when used correctly. So while the Dermavel plasma pen isn’t necessarily FDA approved, it has earned plenty of other certifications, which we will touch on in more detail below.

Other Certifications Dermavel’s Plasma Pen Has

Given how a plasma pen works and the electrical components involved, it requires some additional distinctions like the RoHS certification to make sure that it’s safe for use. So, even though the Dermavel plasma pens aren’t FDA approved, there are a number of other certifications that have been granted to the product that allow you to use it with confidence.

Continue reading as we dig deeper into what each of these certifications are and what that means for the Dermavel’s plasma pens.

CE Certified

An important certification that Dermavel products have is the CE marking. Standing for Conformite Europeeanne, the CE mark is the European Union’s mandatory conformity marking for goods sold within the European Economic Area. This certification has been around since 1985, so it’s a widely-recognized and respected distinction.

There’s no specific governing body that grants CE certification; rather, manufacturers must ensure the CE marking is used appropriately, and that they comply with all the relevant directives and regulations.

So, given that the Dermavel products are CE certified, they are approved for sale in the European market, which is made up of about 30 different countries. Plus, they are proven to comply with the EU’s New Approach Directives, meet recognized performance and safety standards, and do what they’re intended to do without endangering lives or property.

RoHS Certified

Similarly, Dermavel products are also RoHS certified. RoHS stands for “Restriction of Certain Hazardous Substances” in electrical and electronic equipment. Such hazardous substances include lead, mercury, hexavalent chromium, and cadmium, which have proven to be harmful for humans.

With an RoHS certification, a product has been confirmed to have a proportion of hazardous or difficult to dispose substances less than the maximum allowable. The RoHS certification works closely with the CE marking, and Dermavel’s products have met this criteria. So, the Dermavel plasma pens are both CE and RoHS certified.

Are Plasma Pens FDA Approved? Closing Thoughts

Considering what it means to gain FDA approval and what all goes into that process, many plasma pens have not achieved this certification yet. But, this doesn’t mean that they are unsafe to use and should be avoided. Plasma pens can be safe and effective, especially when used under the right conditions. And with other certifications like the EU’s RoHS certification and the CE marking, plasma pens like ours here at Dermavel have been proven to be safe to use and comply with European safety standards.

So to get the dream skin you’ve always wanted, look no further than a plasma pen for taut, glowing, and younger-looking skin. Not to mention, this non-invasive and affordable procedure can even be done from home! The Dermavel plasma pen is the safest, most reputable plasma pen online, so you can use it confidently knowing that you’re going to look and feel your best after using it.

And don’t just take our word for it, take a look at what all the happy customers have to say from Dermavel’s plasma pen reviews, or some of the fibroblast plasma pen before and after photos to see for yourself. Shop Dermavel today to unlock the secret to younger-looking skin that you can achieve from the comfort of your home.