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Global USA Distribution, LLC
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LASERPEEL SOFT-MET MODIFIED ERBIUM LASER is an FDA 510(k)-cleared medical device (K082028) manufactured by Global USA Distribution, LLC. 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 August 7, 2008. Regulation: 8.