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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Generic NameExcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
PMA NumberP990010
Date Received02/23/1999
Decision Date11/19/1999
Product Code LZS 
Docket Number 00M-1447
Notice Date 08/18/2000
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S004 S006 S007 S008