Multi-Center Pilot Study to Evaluate the Safety Profile of High Energy Fractionated Radiofrequency With Insulated Microneedles to Multiple Levels of the Dermis.

In this multi-center pilot study, the safety pro le of high intensity focused radiofrequency (RF) delivered to the dermis was evaluated for safety in the treatment of the aging neck and face. A newly designed insulated microneedle system delivers a signi cant coagulative thermal injury into the dermis while sparing the epidermis from RF injury. Thirty- ve healthy subjects from seven aesthetic practices were evaluated, and data from each were incorporated in this case report. The subjects received a single treatment using settings that delivered the highest RF energies suggested from the new recommended protocols. The depth of thermal delivery was adjusted before each pass and all subjects received a minimum of two to three passes to the treated areas. Before and after photographs along with adverse effects were recorded. This case report demonstrates the ability to deliver significant RF thermal injury to several layers of the dermis with insulated microneedles safely with little injury to the epidermis and minimum downtime.