Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal

Lenses, Soft Contact, Daily Wear

Alcon Laboratories, Inc.

The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Focus Dailies / Focus Dailies Toric / Focus Dailies Progressives, Dailies Aquacomfort Plus (dacp) / Dacp Toric / Dacp Multifocal, Freshlook One-day, Dailies Total1, Dailies Total1 Multifocal.

Pre-market Notification Details

Device IDK180398
510k NumberK180398
Device Name:Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal
ClassificationLenses, Soft Contact, Daily Wear
Applicant Alcon Laboratories, Inc. 6201 South Freeway Fort Worth,  TX  76134 -2099
ContactSherri Lakota
CorrespondentAndreas Friese
Alcon / CIBA Vision GmbH Industriering 1 Grosswallstadt,  DE 63868
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-13
Decision Date2018-04-10
Summary:summary

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