If you are researching plasma pen treatments, you have probably come across the term “FDA-approved” on clinic websites and marketing materials. The problem is that most of the time, that phrase is being used incorrectly — and the distinction matters more than you might think. Understanding what FDA clearance actually means, how it differs from FDA approval, and how to verify a device’s regulatory status yourself puts you in a much better position to evaluate whether the plasma pen being used on your skin has been properly vetted for safety.
Here is what you need to know.
What a Plasma Pen Is and How It Works
A plasma pen delivers an electrical arc to tissue, creating controlled thermal injury. The device, settings, treatment area, and individual healing affect the result; a wound-healing response does not guarantee a particular amount of tightening.
Cosmetic plasma pen treatments are marketed for several skin concerns. They are non-surgical but still injure tissue, and risks include pigment changes and scarring. Incision-free treatment does not establish equivalence to surgery or a guaranteed shorter recovery; the exact device’s cleared indication also matters. Ask about evidence and alternatives if your goal is acne scar improvement.
The technology has grown rapidly in popularity over the past several years, and with that growth has come a wide range of devices on the market. Not all of them have gone through the regulatory process they should have. That is exactly why the FDA question matters.
FDA Clearance vs. FDA Approval: They Are Not the Same Thing
This is the single most important distinction on this topic, and it is the one that gets misrepresented the most. In everyday language, people use “FDA-approved” as a catch-all to mean “the FDA says this is safe.” But the FDA actually has several different regulatory pathways, and the two most relevant to medical devices like plasma pens are approval and clearance. They are different processes with different standards.
FDA approval applies primarily to new drugs and to the highest-risk medical devices (Class III). It requires extensive clinical trial data demonstrating that a product is safe and effective for its intended use. This is the most rigorous pathway and the one most people picture when they hear “FDA-approved.”
FDA clearance is the pathway that applies to most medical devices, including plasma pens. Clearance is granted through a process called 510(k), in which a manufacturer demonstrates that their device is “substantially equivalent” to another device that is already legally marketed in the United States. The FDA reviews the device’s design, intended use, materials, and performance data and determines whether it is comparable enough to a legally marketed device — called a predicate device — to be considered safe and effective for the same intended use.
When a plasma pen has gone through the 510(k) process and received clearance, it means the FDA has reviewed the device and determined it meets the regulatory standard for its classification. That is a meaningful and important step. But it is technically clearance, not approval, and clinics that describe their devices as “FDA-approved” are using the wrong term — whether intentionally or out of genuine confusion.
Does this distinction mean cleared devices are less safe? Not necessarily. It means they went through a different regulatory pathway — one that is appropriate for their risk classification. But it does mean you should look for the right thing when evaluating a device’s regulatory status.
How the 510(k) Process Works
The 510(k) pathway is named after Section 510(k) of the Federal Food, Drug, and Cosmetic Act. Here is how it works in practice.
A device manufacturer submits a premarket notification to the FDA before they intend to market their device. That submission includes detailed information about the device — its design, materials, intended use, performance testing, and a comparison to one or more predicate devices already on the market. The FDA reviews this information and makes a determination: is this device substantially equivalent to something that already has clearance?
If the answer is yes, the device receives 510(k) clearance and can be legally marketed in the United States for its specified intended use. If the answer is no, the manufacturer may need to pursue a different regulatory pathway — such as the de novo process for devices that are low-to-moderate risk but have no clear predicate, or the more rigorous premarket approval (PMA) process for higher-risk devices.
Clearance is specific to the intended use in the FDA record. SubNovii’s record describes skin-lesion removal/destruction and tissue coagulation. A use outside that scope has not been evaluated through that clearance; ask the qualified treating clinician to explain the rationale, evidence, risks, alternatives, and whether it is appropriate for you.
Why This Matters When Choosing a Clinic
The plasma pen market includes devices at every point on the regulatory spectrum. Some have gone through the full 510(k) process and received FDA clearance. Some are manufactured overseas and sold in the United States without any FDA review. Some are marketed with vague language designed to imply FDA involvement without actually having it.
This is not an abstract regulatory concern — it has real implications for your safety. A device that has received 510(k) clearance has been reviewed by the FDA for its design, materials, and intended use. A device that has not gone through that process may not have been evaluated for safety at all. You have no way of knowing what standards it was manufactured to, what testing was performed, or whether the materials in contact with your skin meet any particular safety threshold.
When you are evaluating a clinic for plasma pen treatment, asking which specific device they use and verifying its FDA status is one of the most important due diligence steps you can take. A reputable clinic will be able to tell you the exact device name and manufacturer without hesitation.
How to Check a Plasma Pen’s FDA Status Yourself
You do not have to take a clinic’s word for it. The FDA maintains a publicly searchable database of all devices that have received 510(k) clearance, and anyone can access it.
To verify a plasma pen device, go to the FDA’s 510(k) Premarket Notification database. You can search by the device name, the manufacturer name, or the product code. If the device has received clearance, you will find the full submission details — including the intended use the device was cleared for, the date of clearance, and the predicate device it was compared to.
If a name search returns no result, ask for the manufacturer, exact model, and 510(k) number. A device may be listed under another name. Failure to find one search term is not proof of no review; the actual record and its indication should be checked before relying on a clearance claim.
What About Devices Marketed as “FDA-Registered”?
This is another term you may encounter, and it is worth understanding because it sounds much more official than it actually is. FDA registration means that a device manufacturer has registered their establishment and listed their device with the FDA. That is a basic regulatory requirement for anyone manufacturing or distributing medical devices in the United States — it is essentially a filing obligation, not an evaluation of safety or effectiveness.
Registration does not mean the FDA has reviewed the device. It does not mean the device has been tested. It does not mean the FDA considers it safe. It simply means the manufacturer has notified the FDA that the device exists and that they are marketing it. Any clinic or manufacturer that uses “FDA-registered” as if it carries the same weight as “FDA-cleared” is either confused about the distinction or hoping you are.
The Device We Use at ELLEMES
At ELLEMES Medical Spa, we use the SubNovii Advanced Plasma Technology device for all of our plasma pen treatments. The SubNovii has received 510(k) clearance from the FDA as a Class II medical device for the intended use of “the removal and destruction of skin lesions and coagulation of tissue.”
We chose the SubNovii specifically because of its regulatory standing, its precision, and the consistency of results we see with our patients. Device selection is one of those decisions that happens behind the scenes at a clinic but has a direct impact on your safety and outcomes. We are always happy to discuss the device, its clearance status, and what you can expect from treatment.
Questions to Ask Before Booking a Plasma Pen Treatment
If you are considering plasma pen treatment at any clinic, here are the questions worth asking before you book.
What specific device do you use? You want a brand name and model, not a vague reference to “our plasma pen.” If the provider cannot tell you which device they are using, that is a problem.
Is the device FDA-cleared through the 510(k) process? Listen for the right terminology. “FDA-cleared” is what you want to hear. “FDA-approved” for a plasma pen is technically inaccurate. “FDA-registered” is not the same thing. A knowledgeable provider will understand the distinction.
Can you show me the clearance documentation? A clinic using an FDA-cleared device should be able to point you to the 510(k) record without hesitation — or you can verify it yourself through the FDA’s database linked above.
What training does the provider performing the treatment have? The device matters, but so does the person operating it. Ask about certification, training hours, and how long they have been performing plasma pen treatments specifically.
These are not aggressive or unreasonable questions. Any clinic that is confident in their device and their team will welcome them.
Learn More About Plasma Pen at ELLEMES
If you want a more detailed look at what plasma pen treatment involves — including what it treats, what recovery looks like, and who is a good candidate — visit our main plasma pen treatment page. If you are ready to find out whether plasma pen is the right option for your specific concerns, we are happy to walk you through it.
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ELLEMES Medical Spa is located at 5505 Peachtree Dunwoody Road in Sandy Springs, GA — serving patients from Buckhead, Brookhaven, Dunwoody, and greater Atlanta.
Sources for the clinical information: SubNovii FDA clearance K201738.