FDA Approval Status for TriActive

TriActive LaserDermatology is a therapy that uses mechanical massage combined with six diode lasers to remove body cellulite and result in a smoother skin.

TriActive treatment generally lasts for 20 minutes, in which a diode laser penetrates the affected area and breaks the unwanted fat deposits lying beneath the skin tissue. It is usually performed on the bottom and thighs to have a rejuvenated and tight skin. The Food and Drug Administration (FDA) is an American government agency that evaluates and approves new drugs that are launched in the market after ensuring their efficacy and safety. A New Drug Application (NDA) has to be submitted to FDA to get the approval status.

Cynosure Inc., developer of many cosmetic and health products, received FDA approval for its TriActive system in April, 2005. This laser treatment was in use for many years, but after the FDA clearance, a large number of consumers embraced the product. TriActive was categorized as a Class II non-medical laser, over-the-counter device that allows it to be practiced even by non-physicians like medical aestheticians and certified therapists. Devices that involve laser treatment are often restricted to use only by a qualified physician, but due to TriActive's safety features, this restriction was lifted.

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