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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 K103132
Device Name FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI
Applicant
OCULUS PRIVATE LIMITED
5401 S COTTONWOOD CT.
GREENWOOD VILLAGE,  CO  80121
Applicant Contact Kevin Walls
Correspondent
OCULUS PRIVATE LIMITED
5401 S COTTONWOOD CT.
GREENWOOD VILLAGE,  CO  80121
Correspondent Contact Kevin Walls
Regulation Number886.5925
Classification Product Code
LPL  
Date Received10/25/2010
Decision Date 09/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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