Bluezone is proud to play a role in helping to make our public spaces safer and more accessible during the Covid-19 pandemic, and we’re happy to announce our cutting-edge technology received clearance from the Food and Drug Administration (FDA) as a 510(k) Class II Medical Device.

This designation is contingent upon extensive testing by both Bluezone as well as independent third-party testing, which was conducted in large, room-sized chambers to determine how Bluezone Model 450 units will work in similarly sized, occupied spaces. In addition, units had to prove all FDA safety standards are met.

Through a patented ultraviolet light technology, Bluezone can scrub the air of up to 99.9995 percent of all airborne particles including viruses such as the Covid-causing coronavirus, and with FDA clearance, units can now be offered as a medical device in hospitals, nursing homes, and medical and dental offices to help mitigate the spread of Covid, as well as any other viral aerosols.

“There are few options to decrease the risk associated with airborne viruses that do not create some discomfort and discord,” said Karen Benedek, CEO of Bluezone Proudcts Inc. “Air cleaning with germicidal UV-C is a proven, effective virus reduction method for all occupied spaces. The process of FDA clearance is exhaustive, and we are very pleased that the Model 450 has achieved this milestone.”

In addition to receiving clearance from the FDA, the Bluezone Model 450 units are some of the most accessible and easy-to-use in the marketplace. They are free-standing air purification devices that can simply be plugged into the wall for 24/7 use. They are also safe to operate in occupied environments, unlike other types of air purification technologies.

“UV-C light technology is already recognized as the gold standard for air cleaning and virus destruction. The FDA clearance provides further confirmation of the safety and efficacy of the Bluezone air cleaners in any indoor application,” said Scott Heim, Middleby Division President. leading the Bluezone-by-Middleby effort. “The FDA clearance is important today, especially as mask mandates are ending and we all strive to maintain layers of virus protection in indoor spaces. Effectively and safely cleaning the indoor air at senior living sites and medical locations, as well as restaurants, could not be more urgent.”

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