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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 NameBAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantTECHNOLAS GMBH PERFECT VISION
PMA NumberP990027
Supplement NumberS011
Date Received09/03/2008
Decision Date05/01/2009
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the dynamic rotational eye tracker with iris recognition for use with the bausch & lomb technolas 217z zyoptix laser system for personalized vision correction. The device, as modified, will be marketed under the trade name technolas 217z zyoptix laser system for personalized vision correction and is indicated for: 1) wavefront-guided laser assisted in-situ keratomileusis (lasik) treatments for the reduction or elimination of myopia with sphere up to -7. 00 d and cylinder up to -3. 00 d and mrse < = 7. 50 d at the spectacle plane: reduction or elimination of myopia (nearsightedness) from -1. 00 d to -7. 00 d with less than -3. 00 d astigmatism; 2) reduction or elimination of myopic astigmatism up to -12. 00 d mrse, with sphere between > -7. 00 d to -10. 99 d and cylinder between 0. 00 and < -3. 00 d; and 4) reduction or elimination of low-to-moderate naturally occurring hyperopia up to +4. 00 d mrse, with sphere between +1. 00 d to +4. 00 d with or without refractive astigmatism up to +2. 00 d at the spectacle plane.
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