FDA reviewing ophthalmic laser

San Clemente, CA-Biolase Technology Inc. says the FDA is reviewing its 510(k) regulatory submission to obtain marketing clearance for the Oculase MD laser for use in ophthalmology and oculoplasty.

The company said it aims to market the laser for general tissue ablation, anterior capsulotomy (cataract removal), skin resurfacing, and the treatment of wrinkles around the eye and orbit. Biolase Technology designs, manufactures, and markets proprietary dental laser systems, including a system that uses water and a laser to cut hard and soft dental tissues.