Fibroblasting Pen Update
Plasma Perfecting Co.
We will no longer sell plasma pens that are not US government regulated from our website.
We’ve recently been advised that there is heightened attention from regulatory bodies regarding fibroblasting pens. Practitioners are now more liable to stay current with the legal requirements for plasma pen usage.
The Plamere pen has been listed as a facial massage device. It is no longer listed or registered on the FDA website.
Additionally, the Plaxel Plus and Plagen are not listed on the FDA’s website, while the Plaxpot has a pre-approval 501(k) with the FDA. For providers and professionals, it’s essential to stay aware of these changes and to comply with these new regulations.
For more details, you can review the FDA status here: FDA 510(k) Database: Plaxpot Preapproval
