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www.fdanews.com/articles/71608-cynosure-receives-new-fda-clearance-for-triactive-system

Cynosure Receives New FDA Clearance for TriActive System

April 27, 2005

Cynosure, a developer and manufacturer of cosmetic and medical lasers, announced that it has received a new FDA clearance for the TriActive LaserDermology System, a laser-based system for treating cellulite.

In addition to temporarily improving the appearance of cellulite, TriActive treatments have also been shown to temporarily relieve minor pain and muscle spasms, improve circulation and be used in conjunction with liposuction and other plastic surgery procedures.

The new FDA clearance classifies the System as a "Class II" over-the-counter device. Laser-based medical devices typically require restricted use by or directed use by a physician. However, due to its safety characteristics, the TriActive has been cleared for use by non-physicians such as aestheticians, spa professionals and other therapists.