510(k) K232242

BEAR 2 Body by Foreo, Inc. — Product Code NFO

K232242 is an FDA 510(k) premarket notification submitted by Foreo, Inc. for the device "BEAR 2 Body". The FDA issued a decision of Substantially Equivalent on May 13, 2024. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Foreo, Inc. has at least 9 other 510(k) clearances on record.