DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus 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 Dailies Aquacomfort Plus (sphere), Dailies Aquacomfort Plus Toric, Dailies Aquacomfort Plus Multifocal.

Pre-market Notification Details

Device IDK172066
510k NumberK172066
Device Name:DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-07
Decision Date2017-08-09
Summary:summary

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