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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 K213216
Device Name Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
Applicant
Unicon Optical Co., Ltd.
# 16 Gongye E. 9th Rd., Hsinchu Science Park
Baoshan Township,  TW 30075
Applicant Contact Nick Liao
Correspondent
Eyereg Consulting, Inc.
6119 Canter Ln.
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received09/29/2021
Decision Date 01/18/2022
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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