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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantAMO Manufacturing USA, LLC
PMA NumberP930016
Supplement NumberS014
Date Received06/04/2001
Decision Date11/06/2001
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 01M-0522
Notice Date 11/21/2001
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the visx star s2 and s3 excimer laser systems. The devices are indicated for laser in-situ keratomileusis (lasik) treatments: 1) in patients with documented evidence of a change in manifest refraction of no more than 0. 5 d (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination; and 2) in patients 21 years of age of older in treatments for the reduction or elimination of naturally occurring mixed astigmatism where the magnitude of cylinder (<=6. 0 d at the spectacle plane) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs.
Approval Order Approval Order