FDA.reportPublic FDA data

510(k) K231466

Device
RxSight Insertion Device
Applicant
Rxsight, Inc.
510(k) number
K231466
Product code
MSS
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-12
Date received
2023-05-19
Regulation
886.4300
Classification name
Folders And Injectors, Intraocular Lens (Iol)
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Maureen O'Connell
Address
100 Columbia Aliso Viejo CA US 92656 92656

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MSS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AG2025-09-16
K242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, Incorporated2024-10-10
K231106Accuject Refra Injector AR2900Medicel AG2023-09-19
K231838RxSight® Insertion Device (63002)Rxsight, Inc.2023-08-15
K212039CLAREON MONARCH IV IOL Delivery SystemAlcon Laboratories, Inc.2021-08-23
K200057bioli lOL Delivery SystemAst Products, Inc.2020-06-04
K192926RxSight Insertion DeviceRxsight, Inc.2020-01-17
K192005Bausch + Lomb PreVue Inserter for enVista PreloadedBausch & Lomb, Inc.2019-10-04
K191949UNFOLDER Vitan InserterJohnson & Johnson Surgical Vision, Inc.2019-09-13
K182965BL-Cart IOL Delivery CartridgeAst Products, Inc.2019-03-29
K181401RxSight Insertion DeviceRxsight, Inc.2018-07-26
K172228pioli IOL Delivery SystemAst Products, Inc.2017-12-15
K173480Crystalsert Lens Delivery SystemBausch & Lomb, Inc.2017-12-11
K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company2017-09-06
K161776Lenstec LC Injection systemLenstec, Inc.2016-11-29