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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered laser surgical instrument
510(k) Number K121031
Device Name WAVELIGHT FS200 PATIENT INTERFACE 1505
Original Applicant
ALCON RESEARCH, LTD.
6201 south freeway
fort worth,  TX  76134 2099
Original Contact michael buenger
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HNO  
Date Received04/05/2012
Decision Date 06/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Neurology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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