Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives

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.

Pre-market Notification Details

Device IDK153643
510k NumberK153643
Device Name:Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
ClassificationLenses, Soft Contact, Daily Wear
Applicant ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY Fort Worth,  TX  76134 -2099
ContactSherri Lakota
CorrespondentAndreas Friese
CIBA VISION GMBH INDUSTERIERING Grosswallstadt,  DE 63868
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-21
Decision Date2016-01-20
Summary:summary

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