As of 3/9/21, Molekule is proud to announce that Molekule Air Mini and Air Mini+ have received FDA 510(k) clearance as a Class II medical device. After many months of research and interaction with the FDA, Air Mini and Air Mini+ join Molekule Air Pro RX as air purifiers intended to destroy bacteria and viruses in the air for medical purposes. Air Mini and Air Mini+ are already trusted to clean the air in homes and businesses around the world, and are now also intended for medical purposes to destroy bacteria and viruses in hospitals and other healthcare settings, including home healthcare as well.
To help understand the specifically cleared medical purposes for these devices, please refer to Indications for Use.
Look for enhanced FDA labeling and instructional material on healthcare use and 510(k) compliance on new purchases of Molekule Air Mini and Air Mini+ purifiers. The hardware and underlying PECO technology remain unchanged. Air Mini now also has a non-porous, vegan-leather handle for easier cleaning in medical settings.
Molekule's other air purifiers (Molekule Air and Air Pro) have not been expanded for medical use, however it's important to note that PECO technology underlies all of Molekule's products.
Interested in learning more? Check out our blog post Molekule Air Mini Receives FDA Clearance to Destroy Viruses and Bacteria.