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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tomography, optical coherence
510(k) Number K222166
Device Name SOLIX
Applicant
Optovue, Inc.
2800 Bayview Drive
Fremont,  CA  94538
Applicant Contact Robert Lundberg
Correspondent
Optovue, Inc.
2800 Bayview Drive
Fremont,  CA  94538
Correspondent Contact Robert Lundberg
Regulation Number886.1570
Classification Product Code
OBO  
Subsequent Product Codes
HKI   HLI  
Date Received07/21/2022
Decision Date 11/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT03852485
NCT03887104
NCT04437082
Reviewed by Third Party No
Combination Product No
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