Intelliwave4 With HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)

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 With Hpt, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A).

Pre-market Notification Details

Device IDK152046
510k NumberK152046
Device Name:Intelliwave4 With HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)
ClassificationLenses, Soft Contact, Daily Wear
Applicant ART OPTICAL CONTACT LENS, INC. 3175 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 Received2015-07-23
Decision Date2015-11-24
Summary:summary

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