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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 K223397
Device Name HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens
Applicant
Hoya Lamphun , Ltd.
Hoya Eye Care Thailand Factory, 75/2 Moo 4,
Tambol Banklang,
Amphur Muang,  TH 51000
Applicant Contact Timothy Ting
Correspondent
Hoya Lamphun , Ltd.
Hoya Eye Care Thailand Factory, 75/2 Moo 4,
Tambol Banklang,
Amphur Muang,  TH 51000
Correspondent Contact Timothy Ting
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received11/08/2022
Decision Date 01/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT03859440
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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