The Renuvion®/J-Plasma® system is indicated for the delivery of helium plasma to cut, coagulate and ablate soft tissue during open surgical procedures.
Renuvion/J-Plasma has received a general clearance and has not been determined to be safe or effective for use in any specific procedures or for the treatment of any specific conditions.
The use of the Renuvion/J-Plasma device for Dermal Resurfacing in the US and Canada is considered an off-label procedure.
The use of the Renuvion/J-Plasma device for Dermal Resurfacing in any territory outside of the EU is considered an off-label procedure unless approved by the corresponding territory registration.
Risk associated with the use of Renuvion may include: unintended burns (deep or superficial), pneumothorax, 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. As with all energy devices there are inherent risks associated with its use, refer to the IFU for further information.