Data / Medical devices / United States / Glaukos Corporation

Glaukos Corporation: FDA-registered device maker in San Clemente, CA, United States, 1 510(k) clearance and 2 PMA approvals

Name: Glaukos Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Glaukos Corporation is registered with the FDA (registration 3012833022) in San Clemente, CA, United States. It lists 4 device types. The FDA files 1 510(k) clearance and 2 PMA approvals under its listings, the newest dated August 2, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012833022
FEI number: 3012341472
Address: 229 Avenida Fabricante, San Clemente, CA, United States, 92672
Owner or operator: GLAUKOS CORP. (9050364)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: October 14, 2016
Registered through: 2026
Brand names listed: iAccess Precision Blade, iPrism CLIP, iStent Trabecular Micro-Bypass Stent System, iStent infinite Trabecular Micro-Bypass System Model iS3, iStent inject Trabecular Micro-Bypass System, Model G2-M-IS, iStent inject W Trabecular Micro-Bypass System with Infinite Injector Technology, Model iS2, iStent inject W Trabecular Micro-Bypass System, Model G2-W

Devices it lists

Device	Product code	Class	Role	Source
Implant, Eye Valve	KYF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Intraocular Pressure Lowering Implant	OGO	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Lens, Condensing, Diagnostic	HJL	1	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 2, 2022	K220032	iStent infinite Trabecular Micro-Bypass System, Model iS3	KYF	Substantially Equivalent	Glaukos Corporation	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
June 21, 2018	P170043	iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)	OGO	19	October 1, 2026	accessdata.fda.gov
June 25, 2012	P080030	GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L	OGO	25	April 8, 2026	accessdata.fda.gov

Compare with other makers

Updated October 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.