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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmic Femtosecond Laser
510(k) Number K141476
Device Name WAVELIGHT FS200 LASER SYSTEM
Applicant
Alcon Research, Ltd. Dba Alcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth,  TX  76134
Applicant Contact Bob Lundberg
Correspondent
Alcon Research, Ltd. Dba Alcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth,  TX  76134
Correspondent Contact Amy Tezel
Regulation Number886.4390
Classification Product Code
OOE  
Date Received06/04/2014
Decision Date 09/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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