Med Pen Concepts LLC

Med Pen Concepts LLC specializes in electrosurgical handpieces, which are tools used in surgical and dermatological procedures to cut or coagulate tissue. Their product line includes both reusable and single-use handpieces, such as the PlasmaMD and Plasma+ series, as well as disposable treatment packs like the Professional Plasma Tip Treatment Pack. These devices leverage plasma-based technology for precision tissue treatment.

Med Pen Concepts LLC is based in the United States. While the company operates within the U.S., its devices are designed to comply with applicable regulatory standards for electrosurgical instruments, including those governing Class II medical devices. Individual devices undergo their own regulatory evaluation processes, such as FDA clearance, to ensure safety and effectiveness.

Med Pen Concepts LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory and clinical purposes. This listing applies to their Class II electrosurgical handpieces and associated disposable packs.

Med Pen Concepts LLC’s devices, including their reusable and single-use electrosurgical handpieces like PlasmaMD and Plasma+, are classified as Class II medical devices. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and performance. The classification determines the regulatory pathway for evaluation, such as FDA clearance requirements.