RxSight Insertion Device

Folders And Injectors, Intraocular Lens (iol)

RxSight, Inc.

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

Pre-market Notification Details

Device IDK192926
510k NumberK192926
Device Name:RxSight Insertion Device
ClassificationFolders And Injectors, Intraocular Lens (iol)
Applicant RxSight, Inc. 100 Columbia Aliso Viejo,  CA  92656
ContactMaureen O'connell
CorrespondentMaureen O'connell
RxSight, Inc. 100 Columbia Aliso Viejo,  CA  92656
Product CodeMSS  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOphthalmic
510k Review PanelOphthalmic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-16
Decision Date2020-01-17

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