SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS

Lenses, Soft Contact, Daily Wear

BAUSCH & LOMB, INC.

The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Soflens(tm) One Day Disposable (hilafilcon A) Visibility Tinted Contact Lens.

Pre-market Notification Details

Device IDK974780
510k NumberK974780
Device Name:SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
ClassificationLenses, Soft Contact, Daily Wear
Applicant BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester,  NY  14609 -3547
ContactMichael A Santalucia
CorrespondentMichael A Santalucia
BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester,  NY  14609 -3547
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-22
Decision Date1998-03-11
Summary:summary

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