
Lumenis, Inc.
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ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM is an FDA 510(k)-cleared medical device (K082809) manufactured by Lumenis, Inc.. 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 December 17, 2008. Regulation: 8.