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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 NumberS006
Date Received02/26/1998
Decision Date03/20/1998
Product Code LZS 
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for for 1)laser removal of the epithelium; 2)visibility upgrade; 3)swivel mounted vacuum nozzle; 4)integrated hardware module with all unapproved indications "locked out"; 5)variable Hertz rate from 1.5 to 10 Hertz; 6)smoothing; 7)installation of software Version 2.2 with all unapproved indications "locked out"; and, 8)revised Operator's Manual. The device as modified will be marketed under the trade name VISX START S2 Excimer Laser System and is indicated for myopic and astigmatic PRK using an ablation zone with a 6.0mm 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 patient 18-20 years of age in PRK treatment for the reduction or elimination of myopia (nearsightedness) of less than or equal to -6.0D sphereical equivalent at the corneal plane with less than or equal to -1.0D 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 -12.0D spherical myopia at the spectacle plane and up to -4.0D of astigmatism.