
Cardiogenes
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ECLIPSE 3200(TM) HO:YAG LASER FOR PERCU DISKETOMY is an FDA 510(k)-cleared medical device (K924943) manufactured by Cardiogenes. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 16, 1993. Regulation: 8.