
Skytron, Div. the Kmw Group, Inc.
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AURORA LED SERIES SURGICAL LIGHTS is an FDA 510(k)-cleared medical device (K071698) manufactured by Skytron, Div. the Kmw Group, Inc.. 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 July 5, 2007. Regulation: 8.