NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY

NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY is an FDA 510(k)-cleared medical device (K960584) manufactured by Novavision, 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 August 14, 1996. Regulation: 8.