Summit receives FDA clearance for excimer-laser procedure

April 1, 1995
The US Food and Drug Administration (FDA) granted Summit Technology (Waltham, MA) clearance to market and sell its excimer-laser system in the USA for phototherapeutic keratectomy (PTK)--the treatment of scars, dystrophies, and other pathologic conditions of the cornea. Such conditions can significantly affect a person`s vision by clouding the cornea and creating an opacity. Conventional treatment involves a corneal transplant, which requires a donor and can cost u¥to $10,000. Though PTK off

The US Food and Drug Administration (FDA) granted Summit Technology (Waltham, MA) clearance to market and sell its excimer-laser system in the USA for phototherapeutic keratectomy (PTK)--the treatment of scars, dystrophies, and other pathologic conditions of the cornea. Such conditions can significantly affect a person`s vision by clouding the cornea and creating an opacity. Conventional treatment involves a corneal transplant, which requires a donor and can cost u¥to $10,000. Though PTK offers a much smaller potential market than photorefractive keratectomy--another excimer-laser procedure for which Summit and VISX (Santa Clara, CA) are awaiting FDA approval--the FDA`s clearance of the excimer laser for PTK looks to be a sign that this laser is on its way to being approved for all ophthalmic applications.

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