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Sheaumann Lasers
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SHEAUMANN PL-1064 is an FDA 510(k)-cleared medical device (K111359) manufactured by Sheaumann Lasers. 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 12, 2011. Regulation: 8.