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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 SYSTEM FOR PERSONALIZED VISION CORRECTION
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantBAUSCH & LOMB SURGICAL, INC.
PMA NumberP990027
Supplement NumberS007
Date Received10/21/2004
Decision Date03/15/2006
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) an increase in the laser pulse repetition frequency from the current 50 hz to 100 hz; 2)replacement of the ceratube midi v. 4. 1 laser with the ceratube midi v. 5. 2 laser; 3) software revisions to accommodate the new laser and pulse rate; 4) labeling changes to document these modifications.
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