Data / Medical devices / United States / Glaukos Corporation
Glaukos Corporation: FDA-registered device maker in Aliso Viejo, CA, United States, 1 510(k) clearance and 1 PMA approval
Glaukos Corporation is registered with the FDA (registration 3023475296) in Aliso Viejo, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance and 1 PMA approval 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
- 3023475296
- Address
- 1 Glaukos Way, Aliso Viejo, CA, United States, 92656
- Owner or operator
- GLAUKOS CORP. (9050364)
- Roles
- Specification developer
- First device listed
- June 22, 2018
- Registered through
- 2026
- Brand names listed
- iAccess Precision Blade, 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 | Specification developer | accessdata.fda.gov |
| Intraocular Pressure Lowering Implant | OGO | 3 | Specification developer | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Specification developer | 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 |
Compare with other makers
- All makers of Knife, Ophthalmic
- All makers of Implant, Eye Valve
- All makers of Intraocular Pressure Lowering Implant
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.