GLAUKOS

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3012833022	3012341472	Glaukos Corporation	1	Y	2026-01-01	229 Avenida Fabricante San Clemente CA US 92672
3023475296	3023475296	GLAUKOS CORPORATION	1	N	2026-01-01	1 Glaukos Way Aliso Viejo CA US 92656

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00853704002005	iStent - Trabecular Micro-bypass Stent System - Right	949-367-9600	Quality@glaukos.com

glaukos.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
195917	1379596306	P170043	iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)	OGO	2018-06-21
345822	1379596306	P170043	iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)	OGO	2018-06-21
195917	1472344641	P080030	GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L	OGO	2012-06-25
195917	1198826596	K220032	iStent infinite Trabecular Micro-Bypass System, Model iS3	KYF	2022-08-02
345822	1198826596	K220032	iStent infinite Trabecular Micro-Bypass System, Model iS3	KYF	2022-08-02
195917	1797444675
195917	1972995661
195917	1620608055
345822	1620608055
195917	1683245909
195917	1861378231

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
OGO	3	2018-06-21
KYF	2	2022-08-02

NDC#

EPIOXA CROSS-LINKING

Glaukos Corporation

riboflavin 5-phosphate ophthalmic

Photrexa Cross-linking Kit

Glaukos Corporation

riboflavin 5-phosphate ophthalmic

iDose TR

Glaukos Corporation

Travoprost Intracameral

PMA#

iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi

2022-08-29

GLAUKOS, CORPORATION26051 Merit Circle, Suite 103laguna Hills, CA 92653 PMA NumberP080030 Supplement NumberS024 Date Received05/31/2022 Decision Date08/29/2022 Product Code OGO Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Re...

iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi

2022-08-29

Glaukos Corporation229 Avenida Fabricantesan Clemente, CA 92672 PMA NumberP170043 Supplement NumberS014 Date Received05/31/2022 Decision Date08/29/2022 Product Code OGO Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Pro...

iStent inject® Trabecular Micro-Bypass System Model

2022-02-18

Glaukos Corporation

iStent® Trabecular Micro-Bypass Stent System

2022-02-18

GLAUKOS, CORPORATION

iStent inject W Trabecular Micro-Bypass System

2021-09-10

Glaukos Corporation

iStent inject W Trabecular Micro-Bypass System

2021-08-31

Glaukos Corporation

iStent inject Trabecular Micro-Bypass System

2021-03-03

Glaukos Corporation

iStent inject Trabecular Micro-Bypass System

2020-04-30

Glaukos Corporation

iStent inject Trabecular Micro-Bypass System

2020-04-30

Glaukos Corporation

iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

2019-05-30

Glaukos Corporation

iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

2019-04-16

Glaukos Corporation

iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

2019-04-16

Glaukos Corporation

Glaukos Corporation iStent Trabecular Micro-Bypass Stent System

2018-12-18

GLAUKOS, CORPORATION

iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

2018-06-21

Glaukos Corporation

iStent Trabecular Micro-Bypass Stent System

2018-05-29

GLAUKOS, CORPORATION

Glaukos iStent Trabecular Micro-Bypass Stent System

2018-02-06

GLAUKOS, CORPORATION

GLAUKOS ISTENT TRABECULAR MICRO BYPASS STENT SYSTEM

2016-12-05

GLAUKOS, CORPORATION

GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

2016-09-30

GLAUKOS, CORPORATION

GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

2016-05-13

GLAUKOS, CORPORATION

ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

2015-08-07

GLAUKOS, CORPORATION

GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

2015-07-21

GLAUKOS, CORPORATION

GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

2015-03-24

GLAUKOS, CORPORATION

GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

2014-12-16

GLAUKOS, CORPORATION

GLAUKOS ISTENT TRABECULAR MIRCO-BYPASS STENT SYSTEM

2014-08-29

GLAUKOS, CORPORATION

GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

2013-08-28

GLAUKOS, CORPORATION

GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

2013-06-20

GLAUKOS, CORPORATION

GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

2013-05-01

GLAUKOS, CORPORATION

GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

2013-03-21

GLAUKOS, CORPORATION

GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L

2013-03-08

GLAUKOS, CORPORATION

GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L

2013-03-05

GLAUKOS, CORPORATION

GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L

2013-03-05

GLAUKOS, CORPORATION

GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

2012-11-15

GLAUKOS, CORPORATION

GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

2012-11-08

GLAUKOS, CORPORATION

GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

2012-09-18

GLAUKOS, CORPORATION

GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L

2012-06-25

GLAUKOS, CORPORATION

PMN#

IStent Infinite Trabecular Micro-Bypass System, Model IS3

2022-08-02

Glaukos Corporation

IPrime Viscodelivery System

2022-01-06

Glaukos

Applications#

219910

GLAUKOS

218010

GLAUKOS

GUDID#

iPRIME - Viscodelivery System

GLAUKOS CORPORATION

2022-05-13

iStent inject - Trabecular Micro-Bypass System

GLAUKOS CORPORATION

2018-07-25

iStent - Trabecular Micro-bypass Inserter

GLAUKOS CORPORATION

2015-09-21

iStent - Trabecular Micro-bypass stent system - Left

GLAUKOS CORPORATION

2015-09-21

iStent - Trabecular Micro-bypass Stent System - Right

GLAUKOS CORPORATION

2015-09-21

iStent inject W - Trabecular Micro-Bypass System

GLAUKOS CORPORATION

2020-08-11

iStent infinite - Trabecular Micro-Bypass System

GLAUKOS CORPORATION

2022-10-05

iStent Infinite - Trabecular Micro-Bypass System

GLAUKOS CORPORATION

2022-10-19

iStent inject W Trabecular Micro-Bypass System with Infinite Injector Technology - Trabecular Micro-Bypass System

GLAUKOS CORPORATION

2025-04-30

iAccess - Precision Blade

GLAUKOS CORPORATION

2022-05-13