OxyPure Color Silicone Hydrogel Soft Contact Lenses

Lenses, Soft Contact, Daily Wear

Visco Vision Inc

The following data is part of a premarket notification filed by Visco Vision Inc with the FDA for Oxypure Color Silicone Hydrogel Soft Contact Lenses.

Pre-market Notification Details

Device IDK171447
510k NumberK171447
Device Name:OxyPure Color Silicone Hydrogel Soft Contact Lenses
ClassificationLenses, Soft Contact, Daily Wear
Applicant Visco Vision Inc No. 1, Xingye St., Guishan Dist., Taoyuan City,  TW 33341
ContactEvan Huang
CorrespondentEvan Huang
Visco Vision Inc No. 1, Xingye St., Guishan Dist., Taoyuan City,  TW 33341
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-16
Decision Date2017-12-05
Summary:summary

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