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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Generic Nameexcimer laser system
6848 stapoint court
winter park, FL 32792
PMA NumberP970005
Date Received01/31/1997
Decision Date07/30/1998
Product Code LZS 
Docket Number 00M-0811
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a single laser, Kremer Excimer Laser System Serial No. KEA940202. This device, using a 6.0 mm ablation zone, is indicated for myopic and astigmatic laser in situ keratomileusis (LASIK) in patients: 1)with myopia ranging between -1.0 and -15.0 diopters (D) with or without astigmatism ranging from 0.0 D to 5.00 D; 2) who are 18 years of age or older; and 3) with stable refraction over the 1-year period prior to surgery. Note: Patients between 18 and 20 years old should not demonstrate a shift in refraction greater than 0.5D. Patients 21 years and older should not demonstrate a shift greater than 1.0 D.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling