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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 NumberS012
Date Received07/14/2000
Decision Date04/27/2001
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 01M-0305
Notice Date 07/23/2001
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
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 or older in treatments for the reduction of elimination of naturally occurring hyperopia between +05 and +5. 0 d sphere at the spectacle plane with or without refractive astigmatism up to +3. 0 d, with a maximum manifest refraction spherical equivalent (mrse) of +6. 0 d.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2