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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 K180985
Device Name Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses
Applicant
Supervision Optimax Sdn Bhd
Lot 38, Putra Industrial Park, Bukit Rahman Putra
Sungai Buloh,  MY 40160
Applicant Contact Yap Peak Geeh
Correspondent
Supervision Optimax Sdn Bhd
Lot 38, Putra Industrial Park, Bukit Rahman Putra
Sungai Buloh,  MY 40160
Correspondent Contact Yap Peak Geeh
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received04/13/2018
Decision Date 06/08/2018
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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