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