OPTILINK(TM) LPM (LASER POWER MODULATOR)

OPTILINK(TM) LPM (LASER POWER MODULATOR) is an FDA 510(k)-cleared medical device (K924166) manufactured by Xintec Corporation. 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 February 4, 1993. Regulation: 8.