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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K050948
Device Name PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
Applicant
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609
Applicant Contact ANNE ZAVERTNIK
Correspondent
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609
Correspondent Contact ANNE ZAVERTNIK
Regulation Number886.5925
Classification Product Code
LPL  
Date Received04/15/2005
Decision Date 05/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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