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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K201080
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
Applicant
Visco Vision, Inc.
# 1, Xingye St., Guishan Dist.,
Taoyuan City,  TW 33341
Applicant Contact Evan Huang
Correspondent
Visco Vision, Inc.
# 1, Xingye St., Guishan Dist.,
Taoyuan City,  TW 33341
Correspondent Contact Evan Huang
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received04/22/2020
Decision Date 07/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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