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FDA Updates on Use of Renuvion/J-Plasma Device


Written by Emel Gerdaneri.

FDA Updates on Use of Renuvion/J-Plasma Device

The U.S. Food and Drug Administration (FDA) updated its safety statement issued in March 2022 to inform consumers and healthcare providers for the Apyx Renuvion/J-Plasma device system used for certain aesthetic skin procedures.

The FDA had approved it on May 25, 2022.

FDA stated that 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. Additionally, the FDA continues to warn against the use of Renuvion/J-Plasma for procedures aimed at improving the appearance of the skin through skin contraction.

The FDA also announced that it will continue to monitor reports of adverse events related to the use of the device for aesthetic skin procedures.

The FDA Made Recommendations For Consumers:

j-plasma

  • Discuss the benefits and risks of all available aesthetic skin procedures with your healthcare provider.

  • If you are considering any aesthetic skin treatment, ask what devices your provider will use during the procedure.

  • If you are considering liposuction, ask if your provider plans to use Renuvion/J-plasma during the procedure.

  • If you have any problems or concerns after a procedure using Renuvion/J-Plasma, consult a licensed healthcare provider.

FDA Also Gave Recommendations To Healthcare Providers:

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  • Discuss the benefits and risks of all available aesthetic skin procedures with your patient. If you are having an aesthetic procedure, let your patient know which devices you plan to use.

  • Note that current Renuvion/J-Plasma handpieces are for general use for cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.

  • Do not use Renuvion/J-Plasma alone or in combination with liposuction for skin contraction.

  • Be aware that the use of Renuvion/J-Plasma for skin contraction can result in serious and potentially life-threatening adverse events.


Written on 10/06/2022

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Last Update: 10/06/2022

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