Biotrue ONEday With NaturMoist, Biotrue ONEday For Presbyopia With NaturMoist, Biotrue ONEday For Astigmatism With NaturMoist

Lenses, Soft Contact, Daily Wear

BAUSCH & LOMB INCORPORATED

The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Biotrue Oneday With Naturmoist, Biotrue Oneday For Presbyopia With Naturmoist, Biotrue Oneday For Astigmatism With Naturmoist.

Pre-market Notification Details

Device IDK151918
510k NumberK151918
Device Name:Biotrue ONEday With NaturMoist, Biotrue ONEday For Presbyopia With NaturMoist, Biotrue ONEday For Astigmatism With NaturMoist
ClassificationLenses, Soft Contact, Daily Wear
Applicant BAUSCH & LOMB INCORPORATED 1400 North Goodman Street Rochester,  NY  14609
ContactBarbara Klube-falso
CorrespondentBarbara Klube-falso
BAUSCH & LOMB INCORPORATED 1400 North Goodman Street Rochester,  NY  14609
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-13
Decision Date2016-02-11
Summary:summary

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