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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 K142820
Device Name BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear
Applicant
Abb Optical Group, LLC
1750 N. Loop Rd., Suite 150
Alameda,  CA  94502
Applicant Contact John Kenyon
Correspondent
Compliance Acuity, Inc.
P.O. Box 1490
Golden,  CO  80402
Correspondent Contact Kevin Randall
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/30/2014
Decision Date 04/30/2015
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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