Bausch + Lomb Biotrue ONEday For Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens

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 Bausch + Lomb Biotrue Oneday For Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens.

Pre-market Notification Details

Device IDK143632
510k NumberK143632
Device Name:Bausch + Lomb Biotrue ONEday For Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens
ClassificationLenses, Soft Contact, Daily Wear
Applicant Bausch & Lomb Incorporated 1400 North Goodman Street Rochester,  NY  14609
ContactJessica Burger
CorrespondentJessica Burger
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 Received2014-12-22
Decision Date2015-02-13
Summary:summary

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