FDA.reportPublic FDA data

RxSight Injector Cartridge

Primary DI
10818806020019
Brand
RxSight Injector Cartridge
Company
RXSIGHT, INC.
Model
63000
Device description
Injector Cartridge
Published
2019-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MSSFolders And Injectors, Intraocular Lens (Iol)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSSFolders And Injectors, Intraocular Lens (Iol)Ophthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181401000RxSight Insertion DeviceRxsight, Inc.2018-07-26MSS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818806020019PrimaryGS10
00818806020012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081880602001910818806020019
00818806020012008188060200128188060200120818806020012

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular lens-insertion cartridgeA sterile device designed to contain an intraocular lens (IOL), that may have been pre-folded, to facilitate the insertion (launching) of the folded IOL into the anterior or posterior chamber of the eye through a small incision during ophthalmic surgery. Commonly known as the cartridge, it is typically made of synthetic material and is designed as a funnel-shaped tube that terminates at the distal end in a narrowed opening; the IOL is placed into the wider proximal end. The cartridge is attached to an injector for the insertion, and is removed from the injector once the IOL has been successfully inserted. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
052054413
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818806022481Light Adjustable Lens (LAL)60005-30022025-10-17
00818806022498Light Adjustable Lens (LAL)60005-30012025-10-17
00818806022504Light Adjustable Lens (LAL)60005-30002025-10-17
00818806022511Light Adjustable Lens (LAL)60005-30102025-10-17
00818806022528Light Adjustable Lens (LAL)60005-30202025-10-17
00818806022535Light Adjustable Lens (LAL)60005-30302025-10-17
00818806021750Post Op Eyewear620262025-09-05
00818806021767Post Op Eyewear620272025-09-05
00818806021774RxSight Contact Lens62020-0022025-09-05
00818806020852Light Adjustable Lens (LAL)60007-00302024-12-04
00818806020869Light Adjustable Lens (LAL)60007-00202024-12-04
00818806020951Light Adjustable Lens (LAL)60007-00102024-12-04
00818806021484Light Adjustable Lens (LAL)60007-00002024-12-04
00818806021736Light Adjustable Lens (LAL)60007-00012024-12-04
00818806021743Light Adjustable Lens (LAL)60007-00022024-12-04
00818806020036RxSight Light Adjustable Lens (RxLAL)60005-21002019-04-01
00818806020043RxSight Light Adjustable Lens (RxLAL)60005-21102019-04-01
00818806020050RxSight Light Adjustable Lens (RxLAL)60005-21202019-04-01
00818806020067RxSight Light Adjustable Lens (RxLAL)60005-21302019-04-01
00818806020074RxSight Light Adjustable Lens (RxLAL)60005-21402019-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770602497EyeGility™ InserterBausch & Lomb IncorporatedMSS2026-04-05
10757770618115EyeGility™ InserterBausch & Lomb IncorporatedMSS2026-04-05
10814899027454pioli™ IOL Delivery SystemAST PRODUCTS, INC.MSS2026-04-01
07630055212023ACCUJECT 2.2-1P INJECTOR SETMedicel AGMSS2025-12-09
07630055214584ACCUJECT injector Set 2.1-1PMedicel AGMSS2025-09-30
10818806021016RxSight Insertion DeviceRXSIGHT, INC.MSS2024-11-12
00818806021019RxSight Insertion DeviceRXSIGHT, INC.MSS2024-11-12
00844369016858I9011SLenstec Barbados IncMSS2024-05-06
00844369016865I9012Lenstec Barbados IncMSS2024-05-06
00844369016872I9012FSLenstec Barbados IncMSS2024-05-06
00844369018944LC16Lenstec Barbados IncMSS2024-05-06
00844369018968LC24Lenstec Barbados IncMSS2024-05-06
00844369018975CART45SLenstec Barbados IncMSS2024-05-06
00844369018982CARTMLenstec Barbados IncMSS2024-05-06
00757770520183BLIS-X1Bausch & Lomb IncorporatedMSS2024-03-04
00757770523337BLIS-X0Bausch & Lomb IncorporatedMSS2024-03-04
00757770488964Cystalsert Delivery SystemBausch & Lomb IncorporatedMSS2024-01-18
00757770529032Sofport Easy-Load Lens Delivery System EZ-24Bausch & Lomb IncorporatedMSS2024-01-18
07630055214850Accuject REFRA 2.9 InjectorMedicel AGMSS2023-12-08
07630055211934VISCOJECT 2.2 INJECTOR-SETMedicel AGMSS2023-12-01
07630055211941VISCOJECT 1.8 Injector setMedicel AGMSS2023-12-01
20840311300017MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
20840311300024MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311344796MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311344802MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
10840311300010MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
10840311300027MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311300013MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311300020MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00841668142851ASICO ROYALE III INJECTOR W/ LONG SPRINGKATENA PRODUCTS, INC.MSS2022-12-13