The Renuvion APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.
The Renuvion APR Handpiece has general indications for use as well as indications to improve the appearance of lax skin in the neck and submental region only. The Renuvion APR Handpiece has not been cleared or approved for use with liposuction or in combination with any aesthetic procedure. As with any aesthetic procedure, individual results may vary. As with all energy devices there are inherent risks associated with its use. Risk associated with the use of the Renuvion APR may include: helium embolism into the surgical site due to inadvertent introduction into the venous or arterial blood supply system, unintended burns (deep or superficial), pneumothorax, temporary or permanent nerve injury, ischemia, fibrosis, infection, pain, discomfort, gas buildup resulting in temporary and transient crepitus or pain, bleeding, hematoma, seroma, subcutaneous induration, pigmentation changes, increased healing time, scarring, asymmetry and/or unacceptable cosmetic result. Expected clinical side effects may include discomfort/pain, edema, erythema, ecchymosis, hypoesthesia, touch sensitivity, itching, temporary weight gain, temporary numbness/tingling, subcutaneous nodules or lumps (transient migratory firmness), temporary and/or transient crepitus. Please see the instructions for use for more detailed information.
The Renuvion Dermal Handpiece is indicated for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II, or III.
Warning: Application of more than one treatment pass in the perioral area, on the forehead, and along the jawline has been associated with hypertrophic scarring.
Risks associated with the use of the Renuvion Dermal System include but are not limited to hypertrophic scarring, milia/acne, telangiectasia (spider veins), skin discoloration/hypopigmentation, dormant infection reactivation, infection, bruising or bleeding. 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.
The J-Plasma system is indicated for the delivery of helium plasma to cut coagulate and ablate soft tissue during open surgical procedures. 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 J-Plasma device for Dermal Resurfacing in the US and Canada is considered an off-label procedure. The use of the 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. Risks associated with the use of J-Plasma may include: Helium embolism due to insufflation of gas into the surgical site or due to inadvertent introduction into the venous or arterial blood supply system; ineffective hemostasis; infection of the treatment site post-treatment; unintended injury (burn, scarring, increased healing time) due to excessive treatment; hematoma, pain, erythema, edema, or bleeding. As with all energy devices there are inherent risks associated with its use, refer to the IFU for further information.