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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Folders And Injectors, Intraocular Lens (Iol)
510(k) Number K192926
Device Name RxSight Insertion Device
Applicant
RxSight, Inc.
100 Columbia
Aliso Viejo,  CA  92656
Applicant Contact Maureen O'Connell
Correspondent
RxSight, Inc.
100 Columbia
Aliso Viejo,  CA  92656
Correspondent Contact Maureen O'Connell
Regulation Number886.4300
Classification Product Code
MSS  
Date Received10/16/2019
Decision Date 01/17/2020
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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