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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 K221375
Device Name CureSight-CS100
NovaSight Ltd.
1 Hayarden St.
Airport City,  IL 7019801
Applicant Contact Ran Yam
Regulatory Pathways Group, Inc.
340 S. Lemon Ave. #2471
Walnut,  CA  91789
Correspondent Contact Lee Kramm
Regulation Number886.5500
Classification Product Code
Date Received05/12/2022
Decision Date 09/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT05185076
Reviewed by Third Party No
Combination Product No