
A.R.C Laser GmbH
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FOX 1-980, FOX Q-1064, FOX-Q-810 is an FDA 510(k)-cleared medical device (K073322) manufactured by A.R.C Laser GmbH. 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 February 21, 2008. Regulation: 8.