SAN FRANCISCO, Sept. 2, 2021 /PRNewswire/ -- Molekule today announced that the U.S. Food and Drug Administration (FDA) cleared the 510(k) premarket notification for its existing air purifier, Air Pro, classifying it as a Class II medical device. Air Pro is now cleared for medical use for the destruction of viruses, bacteria, and mold. It joins Molekule's Air Mini, Air Mini+, and Air Pro RX products, which are also FDA cleared for medical use, including in the home, for the destruction of viruses and bacteria in particular.
"We are proud to add the FDA's clearance to another Molekule device. In the wake of so many air quality concerns right now, it has become increasingly important for people to feel confident in the products they choose to help keep the air they breathe cleaner," said Jonathan Harris, CEO of Molekule. "The FDA clearance of our fourth product is another huge milestone in validating our PECO air purification technology as a trusted addition to any home, office space, school, or medical facility."
All of Molekule's air purification devices use the company's patented Photo Electrochemical Oxidation (PECO) technology, an entirely new approach to air purification. Backed by science and 25+ years of research, Molekule's PECO technology goes a step further in air purification with its ability to destroy microscopic pollutants such as viruses, bacteria, mold, allergens, and chemicals.
Air Pro is designed to protect larger spaces and open floor plans, up to 1,000 square feet. It has increased air flow compared to Molekule's other air purifiers, and it harnesses a more finely tuned sensor capability to categorize detected particles into three sizes, from PM10 (pollen) and PM2.5 (dust) to smaller than PM1 (smoke). It can be installed immediately by simply plugging it into the wall. Importantly, Air Pro demonstrated to the FDA that it can achieve greater than 4-log, or 99.99%, reduction of RNA virus MS2 in just thirty minutes.
Few air purifiers on the market today have achieved 501(k) clearance, and today's news marks significant momentum for the company as Molekule now has four FDA cleared products on the market: Air Pro, Air Pro RX, Air Mini and Air Mini+. This certification underscores the company's deep commitment to scientific testing and validation of its PECO air purification technology capabilities, as it works to innovate and move the entire industry forward.
Molekule is on a mission to provide clean indoor air to everyone, everywhere. Based on 25 years of research and development, the company's patented photo electrochemical oxidation (PECO) technology destroys the widest range of pollutants, including VOCs, mold, bacteria, viruses, and allergens, when compared to conventional filters. Molekule's range of air purification solutions have been reviewed and validated by third-party laboratories, as well as continual internal testing, and its medical-grade product has been granted medical device clearance by the FDA. Today, Molekule is available at Home Depot, Best Buy and on Amazon. It is also sold internationally in India, Japan, South Korea, and Canada. For more information and customer reviews, visit https://molekule.com.
Molekule Media Contact
Ali Rae Hunt