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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K103056
Device Name VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
Applicant
CARL ZEISS MEDITEC AG
5160 HACIENDA DRIVE
DUBLIN,  CA  94568
Applicant Contact JUDITH A BRIMACOMBE
Correspondent
CARL ZEISS MEDITEC AG
5160 HACIENDA DRIVE
DUBLIN,  CA  94568
Correspondent Contact JUDITH A BRIMACOMBE
Regulation Number886.4390
Classification Product Code
HQF  
Date Received10/15/2010
Decision Date 02/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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