FDAnews Device Daily Bulletin

BIOLASE ANNOUNCES FDA APPROVAL OF OCULASE MD

Sept. 7, 2005
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BIOLASE Technology, Inc. (NASDAQ: BLTIE), a medical technology company that develops, manufactures and markets lasers and related products for dental and medical applications, announced today that the U.S. Food and Drug Administration (FDA) is reviewing its regulatory submission related to the marketing clearance for the OCULASE MD laser, designed to perform various indications for use in the fields of ophthalmology and oculoplasty. The indications requested are for general tissue ablation, anterior capsulotomy (cataract removal), skin resurfacing, and treatment of wrinkles of tissue surrounding the eye and orbit. The company has been conducting clinical research initiatives and multiple research projects related to its ophthalmic development over the past year in the field of ophthalmology and oculoplasty.

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