Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3

Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 is an FDA 510(k)-cleared medical device (K161198) manufactured by Usa Laser Biotech, 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 July 25, 2016. Regulation: 8.