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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 K070308
Device Name FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR
Applicant
X-Cel Contacts
581 Whiles Ct.
Erie,  CO  80516
Applicant Contact KEVIN RANDALL
Correspondent
X-Cel Contacts
581 Whiles Ct.
Erie,  CO  80516
Correspondent Contact KEVIN RANDALL
Regulation Number886.5925
Classification Product Code
LPL  
Date Received02/01/2007
Decision Date 03/12/2007
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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