LASERSIGHT INCORPORATED RECEIVES FDA CLEARANCE FOR AUTOMATED DISPOSABLE KERATOME IN UNITED STATES.ST. LOUIS--(BW HealthWire)--Jan. 21, 1998--LaserSight Technologies, a wholly-owned subsidiary of LaserSight Incorporated, just received official 510(k) clearance from the U.S. Food and Drug Administration for the company's new Automated Disposable Keratome (ADK ADK Adirondack Mountain Club ADK Archive Development Kit (SAP archiving) ADK Additional Decryption Key ADK Aggressors of Dark Kombat (video game) ) for sale and use in the United States. Keratomes are surgical instruments used to create a thin corneal corneal pertaining to the cornea. See also keratitis, keratopathy. corneal anomaly includes microcornea, coloboma, megalocornea, dermoid, congenital opacity. corneal black body see corneal sequestrum (below). flap during refractive surgery Refractive surgery A surgical procedure that corrects visual defects. Mentioned in: Photorefractive Keratectomy and Laser-Assisted In-Situ Keratomileusis refractive surgery . This disposable keratome was developed by Dr. Luis Antonio Ruiz and engineer Sergio Lenchig of Bogota, Colombia. LaserSight purchased a limited exclusive license to develop the ADK from Ruiz and Lenchig in September 1997. Company managers promptly filed a 510(k) submission to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. on Oct. 22, 1997. Because the ADK comes preassembled and sterile, it does not require disassembly dis·as·sem·ble v. dis·as·sem·bled, dis·as·sem·bling, dis·as·sem·bles v.tr. To take apart: disassemble a toaster. v.intr. 1. , re-sterilization and assembly. LaserSight has received ADK orders from many countries including Australia, Canada, Chile, Argentina, Mexico, Brazil, New Zealand, Colombia, the Philippines, South Africa, Sweden, Japan, Saudi Arabia, Spain, Turkey and China. Last year, company managers had targeted shipping these first ADK orders by the end of January. The company is currently in the final manufacturing validation for the device, and anticipates shipping orders in February. Shipment on orders taken during this month could be expected prior to June. Future ADK orders will be prioritized and shipped according to the date of receipt. Revenues from ADK sales will be reported on a quarterly basis, along with regularly scheduled financial information. LaserSight Incorporated is a technology company dedicated to providing quality, laser-based solutions for refractive refractive capacity to refract light. refractive error a difference between the focal length of the cornea and lens, and the length of the eye, resulting in myopia or hyperopia. , medical and other innovative applications, especially in the vision correction industry. The company sells its laser system in more than 30 countries, and provides consulting and education programs for ophthalmologists. This press release contains forward-looking statements regarding future events and future performance of the company, which involve risks and uncertainties that could materially affect actual results. Investors should refer to documents that the company files from time-time with the Securities and Exchange Commission for a description of certain factors that could cause actual results to vary from current expectations and the forward-looking statements contained in this press release. Such filings include, without limitation, the company's Form 10-K, Form 10-Q and Form 8-K reports. CONTACT: Julie Tockman, APR APR See: Annual Percentage Rate Director, Corporate Relations LaserSight Incorporated (314) 469-3220 Ext. 3060 Visit us on the Internet at www.lase lase - /layz/ To print a given document via a laser printer. "OK, let's lase that sucker and see if all those graphics-macro calls did the right things." .com |
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