510(k) K242288

Advanced Cryo Wart Remover by Medical Brands Laboratories B.V. — Product Code GEH

K242288 is an FDA 510(k) premarket notification submitted by Medical Brands Laboratories B.V. for the device "Advanced Cryo Wart Remover". The FDA issued a decision of Substantially Equivalent on January 21, 2025. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Medical Brands Laboratories B.V. has at least 1 other 510(k) clearance on record.