Risk associated with the use of Renuvion may include: unintended burns (deep or superficial), scars, temporary or permanent nerve injury, pain, discomfort, gas buildup resulting in temporary and transient crepitus or pain, infection, hematoma, seroma; asymmetry and/or unacceptable cosmetic result. There may be additional risks associated with the use of other devices along with Renuvion and there may be an increased risk for patients who have undergone prior surgical or aesthetic procedures in the treatment area. As with any procedure, individual results may vary. The Renuvion system is intended to be used for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. The system is cleared for general use and not for any specific indication or anatomical location. As with all energy devices there are inherent risks associated with its use, refer to the IFU for further information.