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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digital Therapy Device For Amblyopia
510(k) Number K243819
Device Name Luminopia
Applicant
Luminopia, Inc.
955 Massachusetts Ave. #335
Cambridge,  MA  02139
Applicant Contact Scott Xiao
Correspondent
Luminopia, Inc.
955 Massachusetts Ave. #335
Cambridge,  MA  02139
Correspondent Contact Scott Xiao
Classification Product Code
QQU  
Date Received12/12/2024
Decision Date 04/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT06429280
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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