Invictus Sterilization, a Hickory, NC based provider of UV-C-based surface and air sterilization products, said the U.S. Food and Drug Administration (FDA) cleared its Aura Storm as a Class II ultraviolet medical air purifier.
The Aura Storm air purifier is a free standing, air purification device using ultraviolet light and a multi-stage filtration system for the inactivation of bacteria and viruses in hospitals and other medical related facilities. With this clearance, the Aura Storm will now be offered as a medical device to hospitals, nursing homes, hospice facilities, and other medical and dental offices to mitigate risks associated with airborne threats such as the coronavirus, monkeypox, and HAI (Hospital Acquired Infections). The FDA clearance was contingent on an extensive amount of testing conducted at accredited independent third-party testing facilities.
"Invictus is excited to have successfully completed the 510(k)-clearance process," said Invictus CEO Erik McMillan. "Hospital Acquired Infections (HAIs) are responsible for billions of dollars in unnecessary medical expenditures each year. Our Invictus Aura Storm helps to mitigate that by providing the most economical unit on the market in terms of protected area and pathogen coverage per dollar spent. Invictus will continue this journey by having its other units complete the FDA 510(k) certification process in the upcoming months."
