INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT

Lenses, Soft Contact, Daily Wear

ART OPTICAL CONTACT LENS, INC.

The following data is part of a premarket notification filed by Art Optical Contact Lens, Inc. with the FDA for Intelliwave, Soft Daily Wear Contact Lens (acofilcon B) Hioxifilcon B) Clear And Blue Visibility Tint.

Pre-market Notification Details

Device IDK073621
510k NumberK073621
Device Name:INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
ClassificationLenses, Soft Contact, Daily Wear
Applicant ART OPTICAL CONTACT LENS, INC. 806 KIMBALL AVENUE Grand Junction,  CO  81501
ContactMartin Dalsing
CorrespondentMartin Dalsing
ART OPTICAL CONTACT LENS, INC. 806 KIMBALL AVENUE Grand Junction,  CO  81501
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-26
Decision Date2008-07-03
Summary:summary

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