D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM

D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM is an FDA 510(k)-cleared medical device (K012821) manufactured by Dutch Ophthalmic USA, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 21, 2001. Regulation: 8.