Suneva Medical announced today that the FDA accepted updates to its Plasma IQ handheld plasma energy device.
San Diego-based Suneva designed the Plasma IQ for the removal and destruction of skin lesions and coagulation of tissue. The company touts Plasma IQ as the first handheld, FDA-cleared plasma energy device with such indications.
According to a news release, the updated label includes the removal of the product’s eye contraindication, due in part to literature provided to the FDA that showed the safety and efficacy of the ablative device on skin tissue, particularly around the eye area. The new label update allows Suneva to address treatment around the eye for patients in the U.S.
Plasma IQ delivers focused, controlled energy to create micro-injuries on skin, renewing and restoring it. The platform is prescription only, owned and manufactured by Neauvia with Suneva responsible for North American distribution.
Suneva earlier this month entered into a merger agreement with Viveon Health Acquisition Corp., a special purpose acquisition company (SPAC). The company will go public through the merger and expects to trade on the NYSE under the “RNEW” ticker.
“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,” Suneva CEO Pat Altavilla said in the 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.”