Intelliwave4

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 Intelliwave4.

Pre-market Notification Details

Device IDK142641
510k NumberK142641
Device Name:Intelliwave4
ClassificationLenses, Soft Contact, Daily Wear
Applicant ART OPTICAL CONTACT LENS, INC. 3175 3 MILE ROAD Walker,  MI  49534
ContactMichael Johnson
CorrespondentBret Andre
EyeReg Consulting, Inc. 474 NE 61st PL Hillsboro,  OR  97124
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-17
Decision Date2015-01-12
Summary:summary

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