ACUVUE (senofilcon A) Soft Contact Lens Multifocal

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 (senofilcon A) Soft Contact Lens Multifocal.

Pre-market Notification Details

Device IDK200243
510k NumberK200243
Device Name:ACUVUE (senofilcon A) Soft Contact Lens Multifocal
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)
Regulation Medical SpecialtyOphthalmic
510k Review PanelOphthalmic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-31
Decision Date2020-03-17

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