FDA.reportPublic FDA data

RxSight Inc.

Matched from indexed company URL: Rxsight, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30127120273012712027RxSight Inc.1N2026-01-01100 Columbia Aliso Viejo CA US 92656

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1953061602768706P160055LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)PZK2017-11-22
1953061482744176K231838RxSight® Insertion Device (63002)MSS2023-08-15
1953061103258095K231466RxSight Insertion DeviceMSS2023-06-12
1953061575290704K201909RxSight Contact LensHJK2020-09-10
1953062030341967K192926RxSight Insertion DeviceMSS2020-01-17
1953061853422167

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MSS32023-08-15
PZK22017-11-22
HJK12020-09-10

PMA#

Light Adjustable Lens, Light Delivery

2022-11-30

RxSight, Inc.100 Columbiaaliso Viejo, CA 92656 PMA NumberP160055 Supplement NumberS026 Date Received11/09/2022 Decision Date11/30/2022 Product Code PZK  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufactur...

RxSight Light Adjustable Lens and Light Delivery

2022-07-05

RxSight, Inc.100 Columbiaaliso Viejo, CA 92656 PMA NumberP160055 Supplement NumberS023 Date Received06/09/2022 Decision Date07/05/2022 Product Code PZK  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufactur...

PMN#

GUDID#

147 records. Showing 1-40. Next