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March 09, 2021

Molekule Air Mini & Air Mini+ Receive FDA 510(k) Class II Medical Device Clearance

SAN FRANCISCOMarch 9, 2021 /PRNewswire/ — Molekule today announced that the U.S. Food and Drug Administration (FDA) cleared the 510(k) premarket notification for its existing air purifiers, Air Mini and Air Mini+, classifying them as Class II medical devices. Air Mini and Air Mini+ are now cleared for medical use to destroy bacteria and viruses.

“Today’s clearance from the FDA is a proud moment for the company and a huge step for the air purification industry as a whole. Air is extremely complex and contains much more than just particulate matter. That’s why PECO technology was created,” said Jaya Rao, CEO and Co-Founder of Molekule. “The process with the FDA is rigorous and Molekule is pleased that Air Mini and Air Mini+ were able to achieve this milestone. Molekule understands that purchasers need to trust air purifiers, and that’s why it tests its air purifiers against some of the world’s most stringent standards.”

All of Molekule’s air purification devices use the company’s patented Photo Electrochemical Oxidation (PECO) technology, which captures inorganic particulate matter like dust and dander, and oxidizes, or destroys, organic airborne pollutants, specifically, viruses and bacteria. Importantly, Air Mini and Air Mini+ were demonstrated to FDA to have greater than 5-log, or 99.999% reduction of RNA virus MS2, in just two hours. Read rest here