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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameVISX EXCIMER LASER SYSTEM MODEL C "STAR"
Classification Nameexcimer laser system
ApplicantAMO MANUFACTURING USA, LLC
PMA NumberP990010
Date Received02/23/1999
Decision Date11/19/1999
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-1447
Notice Date 08/18/2000
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 the visx excimer laser system model c (star s2) which included the right to reference information contained in p930016 from visx, inc. , of santa clara, ca. This device is indicated to perfrom lasik: 1) in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) from 0 to -14. 0 diopters (d) with or without -0. 5 d to -5. 0 d of astigmatism; and 2) in patients with documented evidence of a change in manifest refraction of less than or equalto 0. 5 d (in both cylinder and sphere components) per year for at least one year prior to the date of pre-operative examination.
Approval Order Approval Order
Supplements: S001 S004 S006 S007 
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