FDA.reportPublic FDA data

RxSight Insertion Device

Primary DI
00818806021019
Brand
RxSight Insertion Device
Company
RXSIGHT, INC.
Model
63002
Device description
RxSight Insertion Device (Single-Use)
Published
2024-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K231838000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231838000RxSight® Insertion Device (63002)Rxsight, Inc.2023-08-15MSS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818806021016PrimaryGS10
00818806021019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081880602101610818806021016
00818806021019008188060210198188060210190818806021019

GMDN Terms#

Term, Definition table
TermDefinition
Manual intraocular lens injector, single-useA hand-held manual ophthalmic surgical instrument designed to expel (launch) a prepared (folded) intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic implantation surgery. It has a central plunger that is activated by a precise mechanism (e.g., a screw thread) and a mechanism at the distal end to hold/grip the insertion cartridge; it is typically made of plastic materials. 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00841668142868ASICO ROYALE III INJECTORKATENA PRODUCTS, INC.MSS2022-12-13