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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
Generic NameExcimer laser system
ApplicantTechnolas Perfect Vision GmbH
Messerschmittstr. 1+ 3
München 80992
PMA NumberP990027
Supplement NumberS007
Date Received09/10/2004
Decision Date03/15/2006
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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