Background Minimally invasive procedures that deliver thermal energy to subcutaneous tissue offer a solution between excisional and non-invasive options to address face and neck, aging-related changes. A minimally invasive helium plasma device, Renuvion, was first used for subdermal tissue heating to reduce skin laxity under a general clearance for cutting, coagulation, and ablation of soft tissue. Objectives The purpose of this study was to demonstrate the safety and effectiveness of the helium plasma device for improving the appearance of loose skin in the neck and submental region. Methods Subjects undergoing a procedure with the helium plasma device in the neck and submentum were studied. Subjects were seen through 6 months post-procedure. The primary effectiveness endpoint was improvement in lax skin in the treatment area as determined by 2 of 3 blinded photographic reviewers. The primary safety endpoint was the level of pain after treatment. Results The primary effectiveness endpoint was met; 82.5% demonstrated improvement at Day 180. The primary safety endpoint was met; 96.9% of subjects experienced no pain to moderate pain to Day 7. There were no serious adverse events reported as related to the study device or procedure. Conclusions The data demonstrates benefit to subjects in improvement of the appearance of lax skin in the neck and submental region. Outcomes resulted in FDA 510k clearance in July of 2022 expanding indications for the device to include subcutaneous dermatological and aesthetic procedures to improve the appearance of loose skin in the neck and submental region.