You might be asking yourself, "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 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 you need to offer plasma fibroblast?
2.) Who should I contact to find out if I am eligible to offer plasma fibroblast with your current qualifications?
3.) What questions should I ask my state officials?
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 board of cosmetology will be the best place of contact for plasma fibroblast regulations specific to your local area. Before you contact them, we'll help you structure your questions and ensure you don't unknowingly trigger a negative response from a state official by using certain buzzwords like plasma fibroblast that they typically don't like, I'll explain more on this below.
1.) Do NOT refer to this treatment as "Plasma Fibroblast". Many state officials will associate this name with the electric pens on the market that burn the skin and this is exactly what we want to get away from by offering True Plasma. The reputation of the name "Plasma 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.
2.) A better name to call this treatment is "collagen induction therapy" or "plasma energy facials". Some estheticians are also calling the PLAXEL 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 why PLAXEL is different from any other pen on the market.
4.) Explain to your cosmetology board that the PLAXEL plasma pen sends a true plasma ENERGY into the epidermis to help REDUCE THE APPEARANCE of sagging skin, fine lines, wrinkles, etc. Do NOT make claims to cure 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 can help your case.
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.
Some states will allow you to offer plasma fibroblast under a tattoo license and if they specifically state plasma fibroblast is permitted some PMU artists can offer plasma under the name "temporary scarification" which is permitted with a tattoo license. Again, check with your state licensing department.
If you are an esthetician AND have a tattoo license, you may want to have one room strictly for tattoos and one room strictly for esthetics, this way if you have an inspector come by and they have problems with you offering plasma fibroblast you can show that it falls under the tattoo license 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 is 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? And 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 is not regulated by the FDA these devices do not need to be FDA registered or approved. There are some exceptions to this but only in a few states that have very strict rules for medical board-certified individuals (nurse practitioner, PA, MD, DO, DC, acupuncturist) and in some cases only allow you to work with FDA-approved or registered devices.
Currently, MEDSUN, the manufacturer of PLAXEL and PLAXEL+ has decided not to pursue FDA approval at this time since the treatment is not regulated by the FDA, and FDA approval or registration is not required to perform plasma in the majority of states across the USA. FDA approval will ultimately increase the cost of the device and price out most of the market from being able to afford this new technology.
There are a few electric device manufacturers on the market that are using a sneaky tactic to get their devices FDA registered but are not being registered to perform Plasma Fibroblast. These devices are being registered as electric massage tools so if you are in a state that requires you to use devices that are FDA registered or approved be sure that the device you are using is actually registered or approved for Plasma Fibroblast and not just as an electric massage tool or it could cause you troubles if an inspector were to find out.
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 Mike from World Plasma LLC, the official USA distributor for PLAXEL and PLAXEL+ in the USA 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