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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact, (Disposable)
510(k) Number K080632
Device Name CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS
Applicant
Clearlab SG Pte, Ltd.
806 Kimball Ave.
Grand Junction,  CO  81501
Applicant Contact MARTIN DALSING
Correspondent
Clearlab SG Pte, Ltd.
806 Kimball Ave.
Grand Junction,  CO  81501
Correspondent Contact MARTIN DALSING
Regulation Number886.5925
Classification Product Code
MVN  
Subsequent Product Code
LPL  
Date Received03/05/2008
Decision Date 10/15/2008
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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