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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Folders And Injectors, Intraocular Lens (Iol)
510(k) Number K133146
Device Name BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
Applicant
Bausch & Lomb
50 Technology Dr.
Irvine,  CA  92618
Applicant Contact SHIVANI K CHITALIA
Correspondent
Bausch & Lomb
50 Technology Dr.
Irvine,  CA  92618
Correspondent Contact SHIVANI K CHITALIA
Regulation Number886.4300
Classification Product Code
MSS  
Date Received10/17/2013
Decision Date 01/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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