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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 (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Neurology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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