510(k) K243487

CryoFreeze Wart and Skin Tag Remover by Cryosurgery, Inc. — Product Code GEH

K243487 is an FDA 510(k) premarket notification submitted by Cryosurgery, Inc. for the device "CryoFreeze Wart and Skin Tag Remover". The FDA issued a decision of Substantially Equivalent on March 13, 2025. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Cryosurgery, Inc. has at least 7 other 510(k) clearances on record.