BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM

BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM is an FDA 510(k)-cleared medical device (K032216) manufactured by Bioptron AG. 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 February 3, 2004. Regulation: 8.