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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Generic NameExcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
PMA NumberP930016
Supplement NumberS005
Date Received07/23/1997
Decision Date01/29/1998
Product Code LZS 
Docket Number 99M-0293
Notice Date 07/15/1999
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
Approval for the VISX Excimer Laser System (Models B and C). This device is indicated for myopic and astigmatic PRK using an ablation zone with a 6.0 mm major axis. The PRK procedure is intended for use: 1)in patients with documented evidence of a change in manifest refraction of less than or equal to 0.5D (in both cylinder and sphere components) per year for at least one year prior to the date of the pre-operative examination; and 2) in patients 18-20 years of age in PRK treatments for the reduction or elimination of myopia (nearsightedness) of less than or equal to -6.0 D spherical equivelent at the corneal plane with less than or equal to -1.0 D of astigmatism; or 3) in patients 21 years of age or older in PRK treatments for the reduction or elimination of myopia (nearsightedness) of between 0 and -12.0 D spherical myopia at the spectacle plane and up to -4.0 D of astigmatism.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness