
Omniguide Communications, Inc.
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OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY is an FDA 510(k)-cleared medical device (K050541) manufactured by Omniguide Communications, 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 May 8, 2005. Regulation: 8.