Glaukos Corp

FDA Filings

This page includes the latest FDA filings for Glaukos Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USA

NEW YORK STOCK EXCHANGE

GKOS

DUNS 012835406

FDA Registration(s)

• Registration Number: 3012833022
• FEI Number: 3012341472
• Name: GLAUKOS CORP. San Clemente
• Owner & Operator: GLAUKOS CORP.
• Contact Address: 229 Avenida Fabricante --; San Clemente CA 92672 US
• Official Correspondent:
  • David - Fernquist
  • x-949-4810100-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 229 Avenida Fabricante ; San Clemente, CA 92672 US
• Establishment Type:
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
Photrexa Cross-linking Kit Glaukos Corporation	Prescription Medication	2024-12-12
Photrexa Cross-linking Kit Glaukos Corporation	Prescription Medication	2024-12-05
iDose TR Glaukos Corporation	Prescription Medication	2023-12-29
Photrexa Cross-linking Kit Glaukos Corporation	Prescription Medication	2023-12-12
Photrexa Cross-linking Kit Glaukos Corporation	Prescription Medication	2023-04-15
GUDID 00853704002449 GLAUKOS CORPORATION	iStent Infinite iS3-US	2022-10-27
GUDID 00853704002470 GLAUKOS CORPORATION	iStent infinite iS3	2022-10-13
Photrexa Cross-linking Kit Glaukos Corporation	Prescription Medication	2022-08-12
PMN K220032 Glaukos Corporation	IStent Infinite Trabecular Micro-Bypass System, Model IS3	2022-08-02
GUDID 00853704002463 GLAUKOS CORPORATION	iAccess AX1	2022-05-23
GUDID 00853704002456 GLAUKOS CORPORATION	iPRIME VCP100	2022-05-23
PMA P170043S012 Glaukos Corporation	iStent inject® Trabecular Micro-Bypass System Model	2022-02-18
PMA P080030S023 GLAUKOS, CORPORATION	iStent® Trabecular Micro-Bypass Stent System	2022-02-18
PMA P170043S010 Glaukos Corporation	iStent inject W Trabecular Micro-Bypass System	2021-09-10
PMA P170043S009 Glaukos Corporation	iStent inject W Trabecular Micro-Bypass System	2021-08-31
PMA P170043S008 Glaukos Corporation	iStent inject Trabecular Micro-Bypass System	2021-03-03
Photrexa Cross-linking Kit Glaukos Corporation	Prescription Medication	2020-12-10
GUDID 00853704002319 GLAUKOS CORPORATION	iStent inject W G2-W	2020-08-19
PMA P170043S007 Glaukos Corporation	iStent inject Trabecular Micro-Bypass System	2020-04-30
PMA P170043S006 Glaukos Corporation	iStent inject Trabecular Micro-Bypass System	2020-04-30
Photrexa Cross-linking Kit Glaukos Corporation	Prescription Medication	2019-11-23
GUDID 00853704002203 Glaukos Corporation	iStent inject G2-M-IS	2019-09-12
GUDID 00853704002029 Glaukos Corporation	iStent GTS100i	2019-09-12
GUDID 00853704002012 Glaukos Corporation	iStent GTS100L	2019-09-12
GUDID 00853704002005 Glaukos Corporation	iStent GTS100R	2019-09-12
PMA P170043S004 Glaukos Corporation	iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)	2019-05-30
PMA P170043S002 Glaukos Corporation	iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)	2019-04-16
PMA P170043S001 Glaukos Corporation	iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)	2019-04-16
PMA P080030S022 GLAUKOS, CORPORATION	Glaukos Corporation iStent Trabecular Micro-Bypass Stent System	2018-12-18
PMN P170043 | OGO GLAUKOS CORP. San Clemente [GLAUKOS CORP.]	iStent inject	2018-06-22
PMA P170043 Glaukos Corporation	iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)	2018-06-21
PMA P080030S021 GLAUKOS, CORPORATION	iStent Trabecular Micro-Bypass Stent System	2018-05-29
Photrexa Cross-linking Kit Glaukos Corporation	Prescription Medication	2018-02-12
PMA P080030S020 GLAUKOS, CORPORATION	Glaukos iStent Trabecular Micro-Bypass Stent System	2018-02-06
HNN GLAUKOS CORP. San Clemente [GLAUKOS CORP.]	iAxis	2018-02-05
HNH GLAUKOS CORP. San Clemente [GLAUKOS CORP.]	iprism CLIP	2017-12-11
NDC 25357-025 Glaukos Corporation	Photrexa Cross-linking Kit	2017-09-25
PMA P080030S019 GLAUKOS, CORPORATION	GLAUKOS ISTENT TRABECULAR MICRO BYPASS STENT SYSTEM	2016-12-05
PMN P080030 | OGO GLAUKOS CORP. San Clemente [GLAUKOS CORP.]	iStent Trabecular Micro-Bypass Stent System	2016-10-14
PMA P080030S018 GLAUKOS, CORPORATION	GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM	2016-09-30
PMA P080030S017 GLAUKOS, CORPORATION	GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM	2016-05-13
NDC 25357-023 Glaukos Corporation	Photrexa	2016-04-15
NDC 25357-022 Glaukos Corporation	Photrexa Viscous	2016-04-15
PMA P080030S013 GLAUKOS, CORPORATION	ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM	2015-08-07
PMA P080030S016 GLAUKOS, CORPORATION	GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM	2015-07-21
PMA P080030S014 GLAUKOS, CORPORATION	GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM	2015-03-24
PMA P080030S012 GLAUKOS, CORPORATION	GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM	2014-12-16
PMA P080030S011 GLAUKOS, CORPORATION	GLAUKOS ISTENT TRABECULAR MIRCO-BYPASS STENT SYSTEM	2014-08-29
PMA P080030S010 GLAUKOS, CORPORATION	GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM	2013-08-28
PMA P080030S009 GLAUKOS, CORPORATION	GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM	2013-06-20
PMA P080030S008 GLAUKOS, CORPORATION	GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM	2013-05-01
PMA P080030S007 GLAUKOS, CORPORATION	GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM	2013-03-21
PMA P080030S004 GLAUKOS, CORPORATION	GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L	2013-03-08
PMA P080030S005 GLAUKOS, CORPORATION	GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L	2013-03-05
PMA P080030S003 GLAUKOS, CORPORATION	GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L	2013-03-05
PMA P080030S001 GLAUKOS, CORPORATION	GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM	2012-11-15
PMA P080030S002 GLAUKOS, CORPORATION	GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM	2012-11-08
PMA P080030S006 GLAUKOS, CORPORATION	GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM	2012-09-18
PMA P080030 GLAUKOS, CORPORATION	GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L	2012-06-25
OGO GLAUKOS CORP. San Clemente [GLAUKOS CORP.]	iStent supra	2009-04-17
OGO GLAUKOS CORP. San Clemente [GLAUKOS CORP.]	iStent inject W	2009-04-17
OGO GLAUKOS CORP. San Clemente [GLAUKOS CORP.]	iStent infinite iS3	2009-04-17

Similar & Related FDA Registered Companies

• 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 Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• 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 Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	8QAP5	GLAUKOS CORPORATION
SEC	0001192448	GLAUKOS Corp of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090378215	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	G2MIS LARGE HOUSING	102 BOX
2020070169282	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	TRAY PACKAGING	42 BOX
2020063059914	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	TRAY PACKAGING	42 BOX
2020061656277	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	G2MIS LARGE HOUSING	99 BOX
2020042266212	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	G2MIS LARGE HOUSING	100 BOX
202003078600	Anvers,Belgium -> Los Angeles, California	TRAY PACKAGING	14 CTN
2020030532527	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	G2MIS LARGE HOUSING	100 PKG
202001134917	Rotterdam,Netherlands -> Los Angeles, California	LARGE HOUSING	199 PKG