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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 K233221
Device Name Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
Applicant
Metro Optics of Austin, Inc.
15802 Vision Dr.
Pflugerville,  TX  78660 -3184
Applicant Contact Steve Webb
Correspondent
Andre Vision and Device Research
6119 Canter Lane
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/28/2023
Decision Date 02/06/2024
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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