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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
AMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2