Safety and Innovation in Aesthetics: Neauvia North America Launches the First and Only FDA Class II Cleared Plasma Device in the U.S. Market

Thursday, March 12, 2020 Drug News
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Neauvia North America has announced that the U.S. Food and Drug Administration (FDA) has given Class II clearance to Plasma IQ, an innovative, non-surgical solution that helps improve the appearance of aging skin in delicate areas of the face. The device utilizes precise plasma technology to give the skin a refreshed and renewed appearance.

RALEIGH, N.C., March 12, 2020 /PRNewswire-PRWeb/ -- Safety and Innovation in Aesthetics: Neauvia North America Launches the First and Only FDA Class II Cleared Plasma Device in the U.S. Market Neauvia North America has announced that the U.S. Food and Drug Administration (FDA) has given Class II clearance to Plasma IQ, an innovative, non-surgical solution that helps improve the appearance of aging skin in delicate areas of the face. The device utilizes precise plasma technology to give the skin a refreshed and renewed appearance.

"Neauvia knows plasma. We are the first and only company to work hand in hand with the FDA to bring Plasma IQ to the aesthetic marketplace for safe and effective use as a Class II device. As the only manufacturer and seller of aesthetic handheld plasma devices in the US, we are able to deliver a device designed for the exacting needs of medical professionals. Neauvia is known worldwide as experts in the research and development of plasma. I could not be happier to bring yet another great Neauvia produced device to the US market," said Sean Wilson, President and CEO of Neauvia North America.

Neauvia's Plasma IQ is important not only to those looking to rewind the signs of aging, but also to the aesthetic industry at large. Though plasma energy has been used for many years across different industries, its application in aesthetic medicine is still relatively new. In a rush to take advantage of the new market opportunity in aesthetics, we have seen other plasma rejuvenation devices come to market with incomplete training and minimal safety and technical support.

Neauvia wanted to find a way to introduce the remarkable benefits of this technology in the U.S. while upholding the stringent quality and patient safety standards the brand is known for globally. The Neauvia team worked hand in hand with the FDA towards the Class II designation with the aim of minimizing risk and improving outcomes for the patients seeking this kind of treatment. The Class II designation ensures that Plasma IQ can only be used by medically licensed and certified practitioners who have been trained by Neauvia.

Plasma IQ is supported by a comprehensive suite of training materials and the company's clinical education is handled in-house, ensuring practitioners are well-prepared to provide safe treatments with impressive results. Plasma IQ providers always have a direct line to Neauvia's in-house medically trained, experts as they learn about and begin to leverage the revolutionary energy-based technologies that the company is bringing to market.

Neauvia's device is the result of years of expertise in end-to-end device manufacturing. Plasma IQ is designed, manufactured and serviced in-house, a process intended to ensure it reliably and consistently performs to the exacting safety and performance standards the company has set forth.

Plasma IQ ionizes the gas particles in the air, creating an arc between the device tip and the skin resulting in micro-injuries that trigger the body's natural healing response. Precise technology and careful technique limit damage to the surrounding area, helping to reduce downtime, improve healing and minimize the risk and severity of side effects.

The device is the second energy-based rejuvenation device in Neauvia North America's product portfolio, which emphasizes a holistic approach to beauty and aging by working synergistically and safely with the body's natural processes. The first device, Zaffiro, combines hydro-exfoliation and thermo-lifting to treat skin laxity and dullness in a wide range of treatment areas across the face and body.

Globally, Neauvia offers an extensive portfolio of products including hyaluronic acid dermal fillers, energy-based devices and clinical-grade skincare. Neauvia remains committed to providing innovative, safe and effective solutions for providers and their patients.

Plasma IQ is FDA cleared to be used in the removal and destruction of skin lesions and the coagulation of tissue. The most common side effects are swelling, tenderness, scabbing, and redness. Plasma IQ is Rx only and should only be used by medically licensed and certified practitioners. For full product and safety information, visit https://neauvia-us.com/plasma-iq/.

For more information on Neauvia North America, visit https://neauvia-us.com/.

 

SOURCE Neauvia North America



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