AXIOM BIOLASER LLLT SERIES-1

AXIOM BIOLASER LLLT SERIES-1 is an FDA 510(k)-cleared medical device (K030622) manufactured by Axiom Usa., 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 September 8, 2003. Regulation: 8.