You might be asking, "what qualifications are required to perform plasma fibroblast?".
"The answer to that question depends on a multitude of factors and is not always an easy answer. Let me explain...Each state across the US is different in the way they regulate treatments like plasma fibroblast, some states have more regulation in place while others have little to no regulation at all, and plasma fibroblast remains in a "grey area".
This guide is designed to help you answer the following questions:
1.) What qualifications do I need to offer plasma fibroblast?
2.) Who should I contact to find out if I am eligible to offer plasma fibroblast with my current qualifications?
3.) What questions should I ask my state officials for plasma fibrobast?
4.) What are some creative ways for me to offer plasma legally? We'll share are few with you 😊
Before diving further into the details it's important to note, we are not legal professionals and none of this information should be taken as legal advice. It is your responsibility to make sure you meet your individual state requirements to offer plasma fibroblast.
How to contact your state officials to see if you are legally able to offer Plasma Fibroblast in your area?
Your state regulatory board will be the best area of contact for plasma fibroblast regulations specific to your local area, this may also be referred to as the board of cosmetology, health department or licensing department. Every state has a different way of managing regulations so you might need to do some google searching to figure out who to call to get accurate info. If you are an esthetician, try contacting your license provider to ask them who can tell you what is allowed within your scope of work. If you hold any other permits or licenses such as a tattoo license, body art or a permanent makeup permit, you can contact the entity that issued this permit or license. Before you contact them, we'll help you structure your questions and ensure you ask the right questions and don't unknowingly trigger a negative response from a state official by using certain buzzwords like "fibroblast" that they typically don't like, I'll explain more on this below.
1.) DO NOT refer to this treatment as "Fibroblast". Many state officials will associate fibroblasting with the electric pens on the market that burn the skin and this is exactly what we want to get away from by offering the new True Plasma technology that the PLAXEL+ offers. The reputation of the name "Fibroblast" has a stigma around it and has been tarnished, especially so with state officials. They've heard the horror stories of electric pens being misused, burning, causing scarring and hyper pigmentation and this is not the attention you want from a state official and it is likely they will automatically jump to a conclusion and categorize you with these electric pens, which you are NOT if you are using PLAXEL+.
2.) A better name to call this treatment is:
- Collagen Induction Therapy
- Plasma Energy Treatments
- Collagen Stimulation Therapy
Some estheticians are also referring to PLAXEL as a high-frequency device similar to the Skin Classic machine.
3.) DO NOT provide the state officials with more information than you are asked for. Again this is to avoid triggering any preconceived conceptions of what this treatment is before you have a chance to explain how PLAXEL is different from any other pen on the market.
4.) Explain to your regulatory officials that the PLAXEL+ device sends an authentic plasma energy into the epidermis without puncturing the skin to help REDUCE THE APPEARANCE of sagging skin, fine lines, wrinkles, etc. Do NOT make any medical claims that the device is designed to cure or treat anything. Their main concern will be that you are ONLY affecting the epidermis and that you are not puncturing the skin with a needle. The PLAXEL+ plasma pen does not directly treat the dermis and the needle tip never actually touches the skin so if you can communicate this to them correctly it will help your case.
Other important information to consider:
If you are only leaving a white dot, which is what we are doing with PLAXEL+, you are technically only exfoliating and not destructing the live tissue. As soon as you start burning the skin, like other pens do, you are destructing live tissue and this is what regulators don't have an issue with. The ball and flat tips the PLAXEL+ offer are totally fine and are a non issue with the state board as no micro-injury is caused while using these tips, and there will be no healing required since these tips are only working superficially to massage the skin with plasma energy.
No luck? Consider getting a Medical Director!
The safest way to offer plasma and avoid all of the regulations is to get a Medical Director. If you are unsure of how to get a Medical Director,
you are welcome to contact us and ask questions or we can recommend a company in the US called Med Spa Advisor that will help put you in touch with a Medical Director in your area.
Their website is www.medspaadvisor.com if you'd like to look into this option.
Not ready for a Medical Director?
Here are a few creative ways you may be able to legally offer plasma fibroblast in your state.
- A lot of esthetic professionals opt to getting a tattoo or body art permit to offer their plasma pen treatments and keep things separate from their esthetician licenses to avoid a lot of the regulation that come with having an esthetician license. Some states are very tough on estheticians and can require a medical director while a tattoo or body art professional is not required to have a medical director. Give it some consideration.
Note: If you have an inspector come through you could in theory show them the ball tip or the cold plasma flat tip which are just massage tools and do not cause any injury to the skin at all. Some providers store the needle tips separately as the needle tips are the main cause of any issues with state officials so this can help you avoid any unwanted attention.
- If you hold both an esthetician license and a tattoo/body art/PMU permit, you may want to have one room strictly for treatments that fall under the tattoo/body art/PMU permit and one room strictly for esthetics under your esthetician license. This way if you have an inspector come by and they have problems with you offering plasma pen treatments you can show them your tattoo/body art/PMU permit and not your esthetician license
- Some states allow you to post a notice on your door that states you offer unregulated services. Since Plasma Fibroblast devices are not regulated by the FDA you may be able to post a notice on your door or window that states that Plasma Fibroblast is an experimental treatment to help reduce the appearance of sagging skin, fine lines, wrinkles and are not yet regulated by the FDA
Of course be sure to check to make sure these work for your state, don't make assumptions.
Is Plasma Fibroblast regulated by the FDA? Do Plasma Pens Need To Be FDA Approved?
No, plasma fibroblast is not regulated by the FDA so the regulation for plasma fibroblast is handled by each state individually.
Since Plasma Fibroblast devices are not regulated by the FDA these devices do not need to be FDA registered or approved.
Why do some devices claim they have FDA approval?
There is a very big difference between a FDA registered device and FDA approved device. It's important not to get these confused. FDA approval is an extremely expensive process that can cost hundreds of thousands of dollars plus yearly maintenance costs for device manufacturers. Some companies have "registered" their devices with the FDA and claim that their device is approved when in fact they are just registered if you look closely. Being registered with the FDA just means you've paid a small fee for a registration and no testing or review has been done by the FDA. If you look closely at device manufacturers that have registered with the FDA, you will notice these pens are being registered as electric massage tools, and not plasma pens.
We know it's complicated and not much fun trying to find accurate information, for that reason we are here to help you and if you want to offer this service badly enough there you will find a way to make it happen!
Stay motivated and don't hesitate to reach out if you need more help! You can text us at (469) 620-7188
Best of luck! 🙏
When you're ready to get started, the PLAXEL+, skincare and training can be purchased on www.plaxelplasma.com