
Lumen Development and Manufacturing, Inc.
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TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER is an FDA 510(k)-cleared medical device (K072995) manufactured by Lumen Development and Manufacturing, 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, 2007. Regulation: 8.