Optixon 1-Day

Lenses, Soft Contact, Daily Wear

Optixon Inc.

The following data is part of a premarket notification filed by Optixon Inc. with the FDA for Optixon 1-day.

Pre-market Notification Details

Device IDK201013
510k NumberK201013
Device Name:Optixon 1-Day
ClassificationLenses, Soft Contact, Daily Wear
Applicant Optixon Inc. 105/106 Ho, 164, Obong-ro, Buk-Gu Daegu,  KR 41500
ContactOh Jeong Ju
CorrespondentEunbae Cho
IGC Co., Ltd. Rm. 501, Daeryung Techno Town 7th, #638, Seobusaet-gil, Geumcheon-gu Seoul,  KR 08504
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-17
Decision Date2020-09-18

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