
Laserscope
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DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT is an FDA 510(k)-cleared medical device (K950662) manufactured by Laserscope. 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 March 9, 1995. Regulation: 8.