Lutronic Receives FDA Clearance for Phototherapy System
Lutronic has announced it has received FDA clearance for a new phototherapy system, according to a news release (pdf).
The Healite II, an 830 nm LED phototherapy system, is cleared for use in temporary relief of minor muscle and joint pain, arthritis and muscle spasm. It can be used as a stand-alone therapy or adjunctive to a wide variety of treatments, including aesthetic laser treatments, according to the company.
"LED phototherapy has been known in the market for many decades by virtue of its various therapeutic benefits. However we wanted our product to stand out from the low-powered and low-quality LED products prevailing in the current market," said R. G. Calderhead, vice president of medical and scientific affairs division of Lutronic, in the release. "Healite II offers technological advances to ensure maximum energy delivery to the tissue and ease of use features that physicians will appreciate."
HEALITE II is globally available with three different wavelengths: 830 nm, 633 nm and 415 nm. FDA clearance is limited to the 830 nm wavelength at this current time.
Lutronic, a developer of lasers and therapeutic devices for aesthetic and medical applications, has its U.S. headquarters in Fremont, Calif.
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