UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL

UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL is an FDA 510(k)-cleared medical device (K134009) manufactured by Medtek Lighting. 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 October 14, 2014. Regulation: 8.