DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 For ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric

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 Total1, Dailies Total1 Asphere, Dailies Total1 For Astigmatism, Dailies Total1 Multifocal, Dailies Total1 Multifocal Toric.

Pre-market Notification Details

Device IDK182782
510k NumberK182782
Device Name:DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 For ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric
ClassificationLenses, Soft Contact, Daily Wear
Applicant Alcon Laboratories, Inc. 6201 South Freeway Fort Worth,  TX  76134
ContactMartina Heim
CorrespondentMartina Heim
Alcon Laboratories, Inc. 6201 South Freeway Fort Worth,  TX  76134
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-01
Decision Date2019-01-18
Summary:summary

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