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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 K101006
Device Name WAVELIGHT FS200 LASER SYSTEM MODEL: FS200
Applicant
Alcon Research, Ltd.
6201 S. Freeway
Fort Worth,  TX  76134 -2099
Applicant Contact MICHAEL BUENGER
Correspondent
Alcon Research, Ltd.
6201 S. Freeway
Fort Worth,  TX  76134 -2099
Correspondent Contact MICHAEL BUENGER
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HNO  
Date Received04/12/2010
Decision Date 10/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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