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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.
 
Trade NameVISX STARR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)
Classification Nameexcimer laser system
Generic Nameexcimer laser for ophthalmic use
ApplicantVISX, INCORPORATED
PMA NumberP930016
Supplement NumberS011
Date Received04/12/2000
Decision Date04/20/2000
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The device, as modified, will be marketed under the trade name visx star s3 excimer laser system (with eye tracker) and is indicated for phototherapeutic keratectomy (ptk), myopic, astigmatic, and hyperopic (sphere only) photorefractive keratectomy (prk) and myopic and astigmatic laser assisted in-situ keratomileusis (lasik).
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