RxSight Contact Lens

Lens, Contact, Polymethylmethacrylate, Diagnostic

RxSight, Inc.

The following data is part of a premarket notification filed by Rxsight, Inc. with the FDA for Rxsight Contact Lens.

Pre-market Notification Details

Device IDK201909
510k NumberK201909
Device Name:RxSight Contact Lens
ClassificationLens, Contact, Polymethylmethacrylate, Diagnostic
Applicant RxSight, Inc. 100 Colombia Aliso Viejo,  CA  92656
ContactMaureen O'connell
CorrespondentMaureen O'connell
RxSight, Inc. 100 Colombia Aliso Viejo,  CA  92656
Product CodeHJK  
CFR Regulation Number886.1385 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-09
Decision Date2020-09-10

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