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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 K100349
FOIA Releasable 510(k) K100349
Device Name VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER
Applicant
JOHNSON & JOHNSON VISION CARE, INC.
7500 CENTURION PKWY.
SUITE 100
JACKSONVILLE,  FL  32256
Applicant Contact CATHERINE DILLON
Correspondent
JOHNSON & JOHNSON VISION CARE, INC.
7500 CENTURION PKWY.
SUITE 100
JACKSONVILLE,  FL  32256
Correspondent Contact CATHERINE DILLON
Regulation Number886.5925
Classification Product Code
LPL  
Date Received02/12/2010
Decision Date 05/21/2010
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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