510(k) K252128

Zener® (model ZEN-001-B1) by Uvx, Inc. — Product Code FRA

K252128 is an FDA 510(k) premarket notification submitted by Uvx, Inc. for the device "Zener® (model ZEN-001-B1)". The FDA issued a decision of Substantially Equivalent on September 15, 2025. The device falls under product code FRA (Purifier, Air, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6500.