FDA approves IPL device for treatment of dry eye disease signs
The FDA has granted de novo authorization to Lumenis for its intense pulsed light device for the management of dry eye disease signs due to meibomian gland dysfunction, according to a press release.
The authorization was based on a multicenter, double-masked, randomized, controlled trial that showed Lumenis IPL with optimal pulse technology (OPT) “significantly improved tear breakup time, meibum quality and meibomian gland expressibility.”
Lumenis also announced it is launching OptiLight, a patented OPT technology, which will be formally unveiled at an upcoming virtual event.
“We’re exceptionally proud to elevate dry eye management and to improve the quality of life for millions of patients,” Tzipi Ozer-Armon, CEO of Lumenis, said in the release. “We are proud to launch OptiLight, a light-based system that provides doctors with a safe and effective dry eye procedure to add to their tool kit.”