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
As a result of these developments, we will no longer carry the Plamere, Plaxel Plus, or Plagen pens to ensure compliance with plasma pen regulations for both practitioners, insurance providers and custom imports. However, we will continue to honor the one-year warranty on any devices purchased within the last year by your followers.
• We do not provide guarantees on any products.
• All pens are drop-shipped from Korea or the US, while devices are drop-shipped from the EU, India, or China.
• Our team does not include medical professionals, and we do not offer medical advice.
• Products have not been evaluated or approved by the FDA, and any statements made regarding these products are not FDA-approved