CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND

CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND is an FDA 510(k)-cleared medical device (K905453) manufactured by Douglas James Donaldson Compliance Services. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 4, 1991. Regulation: 8.