
Onyx Medical, Inc.
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COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT is an FDA 510(k)-cleared medical device (K041679) manufactured by Onyx Medical, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2004. Regulation: 8.