Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012833022

FEI Number

3012341472

Entity Name

Glaukos Corporation

City/State/Country

San Clemente, CA, US

Establishment Address

229 Avenida Fabricante, San Clemente, CA 92672, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

GLAUKOS CORP. (Owner Number: 9050364)

Owner / Operator Contact Address

One Glaukos Way, --, Aliso Viejo, CA 92656, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iAccess Precision Blade iStent inject Trabecular Micro-Bypass System, Model G2-M-IS iStent inject W Trabecular Micro-Bypass System, Model G2-W iStent inject W Trabecular Micro-Bypass System with Infinite Injector Technology, Model iS2 iStent infinite Trabecular Micro-Bypass System Model iS3 iprism CLIP iStent Trabecular Micro-Bypass Stent System iAccess Trabecular Trephine

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-09-21
OGO	Intraocular Pressure Lowering Implant	Unknown	Class 3	N/A	2018-06-22
KYF	Implant, Eye Valve	Ophthalmic	Class 2	886.3920	2022-08-08
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2017-12-11
OGO	Intraocular Pressure Lowering Implant	Unknown	Class 3	N/A	2016-10-14
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2002-03-25

Official Correspondent

David Fernquist

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GLAUKOS CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3023475296	GLAUKOS CORPORATION	Aliso Viejo, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012833022. Last updated year: 2026. Please use registration number 3012833022 when referencing this establishment in official correspondence.