Whether you are a client doing research on the plasma pen used at your local clinic, or a medical professional looking to bring on the plasma pen service for your local spa, it’s important that you know how to determine if your device is considered safe in the eyes of the FDA. So what does it actually mean to get FDA-approval on a medical device and how can you determine if the plasma pen device being used truly is FDA-approved? We will tackle some of these questions in today’s post!
What are Plasma Pens and how are they used for cosmetic treatments?
Before we dive into the FDA-approval process, first we will discuss what exactly the plasma pen is. Plasma pens are a relatively new technology that has been growing in popularity in recent years. They are most often used for cosmetic treatments such as skin tightening or wrinkle reduction.
A plasma pen is a device that uses an electric arc to create a plasma discharge. This discharge is then used to heat and remove material from the surface of the skin. Plasma pens can be used for both medical and cosmetic procedures.
There is some concern about the safety of plasma pens given the newer technology However, when used by a qualified professional, plasma pens have generally proven to be safe and effective. In fact, they may be less risky than some other types of more agressive aesthetic procedures.
If you are considering a plasma pen treatment, make sure to consult with a qualified professional. They can help you decide if this is the right treatment for you and answer any questions you may have about safety.
What does FDA approval actually mean?
FDA approval is the process by which a new drug or medical device is evaluated and determined to be safe and effective for use. The FDA reviews data from clinical trials to assess the safety and effectiveness of a new product or device. If the product meets the standards set by the FDA, it is approved for sale in the United States.
Medical devices that have been approved by the FDA are considered safe and effective, but this does not mean that they are free from risks. All medical devices carry some risk of side effects, so it is important to talk to a professional about any potential risks before trying a new treatment.
How does the FDA approve products?
So contrary to popular beleif, the FDA does not actually approve products, instead, the agency approves specific uses of a product for certain people by approving marketing applications.
If there is an indication that the product could be used in other ways, then it will first require approval through another regulatory pathway to ensure safety and efficacy before its approved for those additional indications. This process ensures patients are exposed to as few risks as possible when available treatments do not meet their needs.
Why should you care about FDA approval?
The FDA is responsible for ensuring the safety and efficacy of medical products in the United States. This means that any product that is marketed as a medication or medical device must be approved by the FDA before it can be marketed to consumers.
There are a few reasons why you should care about FDA approval. First, it ensures that all products on the market are safe and effective. Second, it protects you from being scammed by fraudulent products. And third, it guarantees that all medications and medical devices have been tested before they are made available to consumers.
Using a medical device that has not been authorized by the FDA may be putting your health at risk.
How to tell if your Plasma Pen device is FDA cleared?
To meet the definition of being safe under section 201(h) of the Federal Food, Drug & Cosmetic Act (the Act), plasma pen devices must be shown to be “substantially equivalent” or similar enough in design and intended use as another currently legally marketed product (which is already cleared).
In order to receive this designation, plasma pen manufacturer’s must submit a 510(k) application to the FDA for approval. A 510(k) is a type of FDA notification process that allows a manufacturer to notify the FDA about its intent to market a medical device. There are three types of 510(k) notifications: Type I, Type II and Type III. The first step in what’s known as the “510(k) clearance pathway” is determining what category your product falls into – this will determine what steps the manufacturer needs to take next.
510(k) is just one step of the FDA’s “clearance pathway” – there are other processes that medical device manufacturers need to go through such as the de novo process, reclassification process and what’s known as the Special 510(k). After receiving approval during this process, the devices would then be considered cleared by the FDA for safe and effective for use.
How to tell if your Plasma Pen device is FDA cleared?
If you are curious about wether the device used at your local clinic is authorized by the FDA, you can review whether or not the manufacturer of the plasma pen device has been cleared by the FDA directly from the FDA’s 510(k) Premarket Notification database.
At ELLEMES Medical Spa, we utilize the SubNovii Advanced Plasma Technology Plasma Pen for all of our plasma pen treatments. This device has appropriately received clearance by the FDA as a Class II device under Section 510(k) for the intended use of “the removal and destruction of skin lesions and coagulation of tissue.”
Want to learn more?
If you are looking for a safe and effective solution to treat wrinkles, acne scars or stretch marks, we love the plasma pen treatment! But it’s definitely important to ensure that the device plasma pen device used has been through the appropriate approval process.
Have a question about this procedure? Send us a message, we would love to hear from you!