INTELLIWAVE3

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 Intelliwave3.

Pre-market Notification Details

Device IDK100221
510k NumberK100221
Device Name:INTELLIWAVE3
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 Received2010-01-26
Decision Date2010-09-14
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.