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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 K223575
Device Name Phoenix ICON, Phoenix ICON GO
Applicant
Neolight, LLC
6630 Owens Dr.
Pleasanton,  CA  94588
Applicant Contact Amy Oakes
Correspondent
Neolight, LLC
6630 Owens Dr.
Pleasanton,  CA  94588
Correspondent Contact Amy Oakes
Regulation Number886.1120
Classification Product Code
HKI  
Date Received11/30/2022
Decision Date 09/06/2023
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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