Lumenis Ltd., an energy-based medical device company for ophthalmic, aesthetic and surgical applications and the inventor of intense pulsed light (IPL) technology, has been granted FDA De Novo authorization for a new device to improving symptoms of dry eye disease due to meibomian gland dysfunction (MGD).
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Dry eye disease is a common disorder that affects some 16 million Americans. MGD is the leading cause of dry eye disease, accounting for about 86% of cases.
A multi-center, double-blinded, randomized controlled FDA trial showed that Lumenis IPL with patented Optimal Pulse Technology significantly improved tear breakup time, meibum quality, and meibomian gland expressibility.
Subsequent to the FDA approval, Lumenis is launching OptiLight, to offer a consistent and controlled light-based treatment for dry eye disease symptoms.
