Lumenis wins U.S. & Japanese clearance for retinal laser treatment

November 15, 2013 by Chris Walker

Lumenis Ltd. won FDA 510(k) and Japanese MHLW clearance for its Array LaserLink pattern scanning device for multi-spot retinal laser treatment.

Lumenis wins US & Japanese clearance

Lumenis Ltd. announced today regulatory wins in the U.S. and Japan for its Array LaserLink pattern scanning device for multi-spot laser photocoagulation for use during retinal surgery.

The Array LaserLink, which turns an "examination slit lamp" into a medical laser, expands on the Lumenis laser system to deliver "pattern scanning capabilities, aimed to provide greater predictability in retinal treatments and presumably less collateral damage to the retina," according to a press release.

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"The introduction of the Array LaserLink device in the United States and Japan demonstrates and reaffirms Lumenis' ongoing commitment to developing and introducing advanced ophthalmic laser products and delivery devices that grow with our customers' needs," vice president & ophthalmology strategic business unit general manager Kfir Azoulay said in prepared remarks. "We believe Array will bring important benefits both to patients, clinicians and health care providers; and we look forward to working with the ophthalmology community to integrate our next generation technology into clinical practice."

The Yokneam,Israel-based medical laser company was hit with a Class I FDA recall in February. The FDA warned that Lumenis' VersaCut tissue morcellator could cause air embolisms, which had the potential of causing death.