510(k) K232645

Airgle Room Air Purifier by Airgle Corporation — Product Code FRA

K232645 is an FDA 510(k) premarket notification submitted by Airgle Corporation for the device "Airgle Room Air Purifier". The FDA issued a decision of Substantially Equivalent on February 16, 2024. The device falls under product code FRA (Purifier, Air, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6500.