
Castle Co.
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DAYSTAR SURG. LIGHT 9100 & ORBITER 9110 is an FDA 510(k)-cleared medical device (K771865) manufactured by Castle Co.. 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 27, 1977. Regulation: 8.