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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 K030027
Device Name GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%
Applicant
Gelflex Laboratories
3 Hutton St., Osborne Park
Perth, Western, Wa,  AU 6017
Applicant Contact PETER G BRYANT
Correspondent
Gelflex Laboratories
3 Hutton St., Osborne Park
Perth, Western, Wa,  AU 6017
Correspondent Contact PETER G BRYANT
Regulation Number886.5925
Classification Product Code
LPL  
Date Received01/03/2003
Decision Date 04/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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