Search Results
Found 2 results
510(k) Data Aggregation
K Number
K220032Device Name
iStent infinite Trabecular Micro-Bypass System, Model iS3
Manufacturer
Glaukos Corporation
Date Cleared
2022-08-02
(209 days)
Product Code
KYF
Regulation Number
886.3920Why did this record match?
Applicant Name (Manufacturer) :
Glaukos Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iStent infinite® Trabecular Micro-Bypass System Model iS3 an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed.
Device Description
The iStent infinite Trabecular Micro-Bypass System Model iS3 is a sterile, single-use injector system that is pre-loaded with three G2-W stents, and is designed to deliver the stents into Schlemm's canal. The G2-W stents are manufactured from implant grade titanium (Ti6Al4V ELI per ASTM F136) and are coated with stearalkonium heparin. An area of reduced outside diameter, midway along the device, is designed to provide retention within the trabecular meshwork, while multiple outlet lateral lumens (4 outflow orifices) are designed to provide an exit route for aqueous from the anterior chamber. The stent has a single piece design, is 360 um in diameter, 360 um in height, and the central inlet and outlet lumen has a diameter of 80 um. The head of the stent has four side outlets that each have a diameter of 50 um.
Ask a Question
K Number
K212797Device Name
iPrime Viscodelivery System
Manufacturer
Glaukos
Date Cleared
2022-01-06
(126 days)
Product Code
MRH
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
Glaukos
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iPRIMETM Viscodelivery System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example HEALON® PRO from Johnson & Johnson Vision, Amvisc@ from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery.
Device Description
The iPRIMET™ Viscodelivery System is a sterile, single-use ophthalmic surgical instrument for dispensing cohesive viscoelastic fluid (supplied separately, at point of use) during ophthalmic surgery. The iPRIMET™ Viscodelivery System is a delivery device for delivering viscoelastic fluid. The procedure is performed by a trained ophthalmic professional in a sterile surgical setting. The iPRIME device is filled by the user, at the point of use, with FDA approved commercially available cohesive viscoelastic fluid (e.g. HEALON® PRO, Amvisc® or PROVISC®; sold and supplied separately). The iPRIME device consists of a handpiece which includes a reservoir, dispense trigger, cannula, slide button, rotatable hub, and microcatheter manufactured from medical grade materials. The slide button allows the user to adjust the microcatheter length. The dispense trigger dispenses the viscoelastic fluid. The rotatable hub allows the user to adjust the angle of the cannula in order to dispense viscoelastic fluid into other areas within the anterior chamber. The iPRIMET™ Viscodelivery System serves as dispensary means to deliver cohesive viscoelastic fluid. The OVD device containing the viscoelastic fluid is connected to the iPRIME luer fitting and viscoelastic is pumped into the iPRIME device. After the device is fully primed and the microcatheter has been extended to the desired location, the user advances forward the dispense trigger delivering a small amount of viscoelastic fluid into the desired location within the anterior chamber of the eye.
Ask a Question
Page 1 of 1