ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA

Lenses, Soft Contact, Daily Wear

JOHNSON & JOHNSON VISION CARE, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Vision Care, Inc. with the FDA for Acuvue (etafilcon A) Soft Contact Lens For Presbyopia.

Pre-market Notification Details

Device IDK141670
510k NumberK141670
Device Name:ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA
ClassificationLenses, Soft Contact, Daily Wear
Applicant JOHNSON & JOHNSON VISION CARE, INC. 7500 CENTURION PARKWAY, SUITE 100 Jacksonville,  FL  32256
ContactScott Durland
CorrespondentScott Durland
JOHNSON & JOHNSON VISION CARE, INC. 7500 CENTURION PARKWAY, SUITE 100 Jacksonville,  FL  32256
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-23
Decision Date2014-09-18
Summary:summary

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