The FDA has updated its safety communication to inform consumers and health care providers about a new handpiece for the Apyx Renuvion/J-Plasma device system, that can now be used for certain aesthetic skin procedures.
The Renuvion/J-Plasma system by Apyx Medical is a medical device with a handpiece and plasma generator, that uses radiofrequency (RF) energy and helium to generate plasma (gas-like substance with high heat).
The FDA cleared the Renuvion Dermal Handpiece to be used with the Apyx Medical Helium Plasma Generator for the treatment of moderate to severe wrinkles and rhytids, limited to patients with Fitzpatrick Skin Types I, II or III. The labeling and training for the new handpiece include instructions for device power settings and number of treatment passes, separate from existing Renuvion/J-Plasma handpieces that are cleared for general use of cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.
The use of the Renuvion Dermal Handpiece has not been determined to be safe or effective for all dermal resurfacing procedures, or in patients with Fitzpatrick Skin Types IV, V or VI.
Recommendations for health care providers:
- Discuss the benefits and risks of all available aesthetic skin procedures with your patient. If performing an aesthetic procedure, inform the patient which devices to be used.
- Be aware that a new handpiece, the Renuvion Dermal Handpiece, has been cleared by the FDA to be used with Apyx Medical Helium Plasma Generators for the treatment of moderate to severe wrinkles and rhytids in patients with Fitzpatrick Skin Types I, II or III.
- Be aware that existing Renuvion/J-Plasma handpieces are cleared for the general use of cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.
- Do not use Renuvion/J-Plasma for skin contraction, alone or in combination with liposuction.
- Be aware that the use of Renuvion/J-Plasma for skin contraction may result in serious and potentially life-threatening adverse events.
- Report any problems or complications experienced by patients from procedures using Renuvion/J-Plasma to the FDA.
