
Douglas James Donaldson Compliance Services
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CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE is an FDA 510(k)-cleared medical device (K912987) manufactured by Douglas James Donaldson Compliance Services. 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 27, 1991. Regulation: 8.