Indications for Use

The AYON Body Contouring System™ is intended for the fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring.

  • The AYON Body Contouring Ultrasound Sub-System is used for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring.
  • The AYON Body Contouring Infiltration and Aspiration Sub-System(s) are used for the infiltration and suction / aspiration of fluids and tissue during surgical procedures. Infiltration and Suction is designed to operate as a stand-alone function

The AYON Body Contouring System™ may also accommodate other equipment, including commercially available electrosurgical generators owned by Apyx Medical, such as the APYX-ONE Console.

The Renuvion APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue. The Renuvion APR Handpiece is intended for the coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring. 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 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 intended to be used with compatible electrosurgical generators owned by Apyx® Medical. Not all indications are approved in all markets; check with your local sales representative for further information.

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. Risks associated with the use of the AYON Body Contouring System™ may include: hyper- or hypovolaemia, cardiac arrhythmias, venous thromboembolism, fat embolism, visceral perforation, burn, seroma, vasculitis, bleeding, bruising or hematoma fibrosis, infection, skin erythema, hyper- or hypopigmentation, hyperesthesia, hyper- or hypotension, temporary or permanent nerve damage, and 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 Apyx One Console is indicated for delivery of radiofrequency energy and/or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures.

The helium plasma portion of the generator can be used only with dedicated Renuvion/J-Plasma handpieces.