The Bespoke Cube Air from Samsung Electronics

Samsung Electronics’ new air purifier model, Bespoke Cube Air, has recently obtained marketing clearance (510k, Class 2) from the U.S. Food and Drug Administration (FDA).

The company submitted a premarket notification on its new air purifier to the FDA in October 2021 and received an order a month later. 

The premarket notification, or 510(k) submission, is a mechanism through which the majority of medical devices obtain U.S. marketing clearance. A 510(k) submission must demonstrate that the device is substantially equivalent (SE) to one or more devices legally marketed in the U.S. with the same intended use. If the device is found SE by FDA, it is cleared for commercial distribution and may be marketed. 

The Bespoke Cube Air is an air purifier in the form of a cube, launched by Samsung Electronics in December 2020. The air purifier is loaded with a photocatalytic ultraviolet sterilization function to eliminate bacteria and viruses in the air. When bacteria are injected into the filter, the air purifier can get rid of 99 percent of major bacteria such as bacteriophages, yellow staphylococcus and coliforms, in three hours.

“Unlike air purifiers for ventilators commonly used in general hospitals and operating rooms, the Cube Air can remove bacteria and viruses in the air on the floor,” Samsung Electronics said in a submitted document. “The Cube Air can be controlled with a mobile app as it has a WLAN device inside.”

“Just as LG Electronics’ semi-permanent electronic mask was approved as a medical device by the U.S. FDA, the Cube Air Purifier has also been approved as a medical device in the United States,” said an official of the medical device industry. The FDA classifies medical device certification into Classes 1, 2, and 3. Class 2 give to the Cube Air stands at the level of medical devices for general hospitals and homes.

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Originally Appeared Here