510(k) K212121

VHT-200 Wound Treatment System by Vaporox, Inc. — Product Code KPJ

K212121 is an FDA 510(k) premarket notification submitted by Vaporox, Inc. for the device "VHT-200 Wound Treatment System". The FDA issued a decision of Substantially Equivalent on March 23, 2023. The device falls under product code KPJ (Chamber, Oxygen, Topical, Extremity), a Class II device regulated under 21 CFR 878.5650. Vaporox, Inc. has at least 1 other 510(k) clearance on record.