This article was originally published in The Gray Sheet
Executive SummaryPremarket approval application for firm's excimer laser to treat myopia via photorefractive keratectomy (PRK) will be reviewed by FDA's Ophthalmic Devices Advisory Panel at a meeting scheduled for Oct. 20 in Gaithersburg, Maryland, according to Summit. The firm received an approvable letter from the agency on June 10 for use of its laser in phototherapeutic keratectomy ("The Gray Sheet" June 13, In Brief). Summit's main competitor in the ophthalmic laser market, Santa Clam, California-based Visx, says that the PMA for its Twenty/Twenty excimer laser for PRK will not be reviewed at the October panel meeting
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