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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Refractor, 3d Display
510(k) Number K233295
Device Name LFR-260
Applicant
Evolution Optiks Limited
Pasea Financial Centre
Corner Harts Gap & Dayrells Rd.
Christ Church,  BB BB14030
Applicant Contact Raul Mihali
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number886.1770
Classification Product Code
SBI  
Date Received09/29/2023
Decision Date 05/31/2024
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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