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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Nameexcimer laser system
Generic Nameophthalmic excimer laser system
PMA NumberP970005
Date Received01/31/1997
Decision Date07/30/1998
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-0811
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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