IRIS OCULIGHT(R) SLX

IRIS OCULIGHT(R) SLX is an FDA 510(k)-cleared medical device (K913430) manufactured by Iriderm Div.. 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 November 14, 1991. Regulation: 8.