FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions

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 Freshlook Handling Tint, Freshlook Colors, Freshlook Colorblends, Freshlook Dimensions.

Pre-market Notification Details

Device IDK181796
510k NumberK181796
Device Name:FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions
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 Received2018-07-05
Decision Date2018-08-03
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.