510(k) K953294

CANDELA CRYOSYSTEM CS-5 by Candela Laser Corp. — Product Code GEH

K953294 is an FDA 510(k) premarket notification submitted by Candela Laser Corp. for the device "CANDELA CRYOSYSTEM CS-5". The FDA issued a decision of Substantially Equivalent on October 18, 1995. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Candela Laser Corp. has at least 10 other 510(k) clearances on record.