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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 K261174
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 Received04/09/2026
Decision Date 06/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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