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Home » Cutera’s Enlighten Laser Platform Clears 510(k) Hurdle

Cutera’s Enlighten Laser Platform Clears 510(k) Hurdle

August 12, 2014

Laser systems maker Cutera said Tuesday that its enlighten laser platform received FDA 510(k) clearance for the treatment of benign pigmented lesions. The device is the first dual wavelength and dual pulse duration picosecond laser system cleared for sale in the U.S., the Brisbane, Calif., company said.

The enlighten platform, which joins Cutera’s excel V and excel HR laser systems, features efficient power generation and ergonomic design, according to the company. The dual wavelengths and durations plus the ability to adjust fluence and spot size provide practitioners with the broadest range of treatment settings, said CEO Kevin Connors.

Cutera is seeking 510(k) clearance to use enlighten for tattoo removal.

Commercial shipments of enlighten will launch in the fourth quarter of this year. — Kellen Owings

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