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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lens, contact, polymethylmethacrylate, diagnostic
510(k) Number K201909
Device Name RxSight Contact Lens
RxSight, Inc.
100 Colombia
Aliso Viejo,  CA  92656
Applicant Contact Maureen O'Connell
RxSight, Inc.
100 Colombia
Aliso Viejo,  CA  92656
Correspondent Contact Maureen O'Connell
Regulation Number886.1385
Classification Product Code
Date Received07/09/2020
Decision Date 09/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No