510(k) K243788

IceCap product line by Bioserenity Medical Devices Group — Product Code GXY

K243788 is an FDA 510(k) premarket notification submitted by Bioserenity Medical Devices Group for the device "IceCap product line". The FDA issued a decision of Substantially Equivalent on March 13, 2025. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320.