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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 K050743
Device Name AQUAFLEX 2 (TEFILCON) CONTACT LENS
Applicant
Unilens Corp., USA
10431 72nd St., N.
Largo,  FL  33777
Applicant Contact JOSEPHA BRUNO
Correspondent
Unilens Corp., USA
10431 72nd St., N.
Largo,  FL  33777
Correspondent Contact JOSEPHA BRUNO
Regulation Number886.5925
Classification Product Code
LPL  
Date Received03/21/2005
Decision Date 04/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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