AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS

Lenses, Soft Contact, Daily Wear

COOPERVISION, INC.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Aquasoft (tetrafilcon A) Daily Wear Soft (hydrophilic) Contact Lens.

Pre-market Notification Details

Device IDK954139
510k NumberK954139
Device Name:AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
ClassificationLenses, Soft Contact, Daily Wear
Applicant COOPERVISION, INC. 10 FARADAY Irvine,  CA  92618
ContactAmy Blazak
CorrespondentAmy Blazak
COOPERVISION, INC. 10 FARADAY Irvine,  CA  92618
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-01
Decision Date1995-11-24

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