Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens

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 Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens.

Pre-market Notification Details

Device IDK201080
510k NumberK201080
Device Name:Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens
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 Received2020-04-22
Decision Date2020-07-15

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.