Plasma IQ is the first FDA approved handheld plasma energy device indicated for the removal and destruction of skin lesions and coagulation of tissue
Plasma IQ is the first FDA approved handheld plasma energy device. (Credit: Sofie Zbořilová from Pixabay)
Suneva Medical announced that the US Food and Drug Administration (FDA) has accepted the updates to the Plasma IQ label, to include the removal of the product’s eye contraindication.
The removal of specific contraindication was partly based on literature provided to the US FDA, showing safety and efficacy of the ablative device on skin tissue, mainly around the eye area.
With the label update, the regenerative aesthetics company is enabled to provide US patients with treatment around the eye.
Suneva chief executive officer Pat Altavilla said: “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.
“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.”
According to Suneva, Plasma IQ is the first FDA approved handheld plasma energy device for the removal and destruction of skin lesions and coagulation of tissue.
The device leverages latest advancements in aesthetics, to deliver focused, controlled energy to create microinjuries on the skin, for renewing and restoring it.
Plasma IQ is a prescription only device, indicated for use only by medically licensed and certified practitioners.
It is owned and manufactured by Neauvia and Suneva is responsible for distribution of Plasma IQ across North America.
Suneva is focused on developing, manufacturing and commercialising branded products for providers and their patients.
It provides a portfolio of products to address the impact of aging process to deliver solutions that leverage the body’s own restorative capacity.
Earlier this month, Suneva has entered into a definitive merger agreement with Viveon Health Acquisition, a special purpose acquisition company (SPAC).
Upon closing of the transaction, the combined company will trade its securities on the New York Stock Exchange (NYSE).