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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 K192129
Device Name ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens
Applicant
Clearlab SG Pte, Ltd.
139 Joo Seng Rd. #01-01
Singapore,  SG 368362
Applicant Contact John Christopher Phelan
Correspondent
Clearlab Us, Inc.
4200 Jenkins Ct.
Suwanee,  GA  30024
Correspondent Contact John Christopher Phelan
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received08/07/2019
Decision Date 09/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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