New Renuvion/J-Plasma Handpiece Available: FDA

In its latest safety communication update on using a Renuvion/J-Plasma device for certain esthetic procedures, FDA says it cleared 7/15 the Renuvion APR Handpiece for use in subcutaneous dermatological and esthetic procedures to improve the appearance of lax skin in the neck and submental region. The update says the labeling and training for the new handpiece will include updated instructions for device power settings and treatment parameters specific to use in procedures under the skin for the neck and chin regions.

“It is important to note that use of the Renuvion APR Handpiece has not been cleared or approved for use in any other esthetic skin procedure, or in combination with liposuction,” FDA says.

An initial 3/2022 safety communication warned against using the Renuvion/J-Plasma device for procedures intended to approve the appearance of the skin through dermal resurfacing or skin contraction. A 6/2022 notice advised of agency clearance of the Renuvion Dermal Handpiece.