FDA Accepts Label Update for Suneva’s Plasma IQ

The label update allows Suneva to address treatment around the eye.

Plasma IQ label, including the removal of the product's eye contraindication. 

The removal of this specific contraindication was due in part to a compilation of literature provided to the FDA showing the safety and efficacy of the ablative device on skin tissue, particularly around the eye area. This label update allows Suneva to address treatment around the eye with patients in the United States.

"On the heels of our announcement of the planned merger with Viveon Health Acquisition Corp. to build on our leadership in the regenerative aesthetics sector, we are pleased with the FDA's decision to update the Plasma IQ label," says Pat Altavilla, Chief Executive Officer of Suneva, in a news release. "We believe Suneva's innovations have always been led by science and I look forward to working with our partner Neauvia to provide access of our Plasma IQ device to a larger patient population looking to improve their aesthetics through a focused energy treatment."

Plasma IQ is the first handheld FDA-cleared plasma energy device indicated for the removal and destruction of skin lesions and coagulation of tissue. It delivers focused, controlled energy to effectively create microinjuries on the skin, renewing and restoring it. Plasma IQ is owned and manufactured by Neauvia. Suneva is responsible for distribution of Plasma IQ within North America.