
Iriderm Div.
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IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED is an FDA 510(k)-cleared medical device (K903288) 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 September 23, 1990. Regulation: 8.