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 e…