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 was incorrectly registered as a facial massager device. The Plamere pen is not registered or approved for fibroblasting. Additionally 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 more details, you can review the FDA status here:  

 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K220493