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Luxsano AB
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OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM is an FDA 510(k)-cleared medical device (K032191) manufactured by Luxsano AB. 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 August 19, 2003. Regulation: 8.