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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K242508
Device Name Verily Numetric Retinal Camera
Applicant
Verily Life Sciences, LLC
269 E Grand Avenue
South San Francisco,  CA  94080
Applicant Contact Shah Pooja
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number886.1120
Classification Product Code
HKI  
Date Received08/22/2024
Decision Date 12/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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