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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 STAR S2 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameeximer laser for ophthalmic use
ApplicantVISX, INCORPORATED
PMA NumberP930016
Supplement NumberS006
Date Received02/26/1998
Decision Date03/20/1998
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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.
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