Chrysalis Intelligence · Sponsors · Glaukos Corporation

Glaukos Corporation

San Clemente, CA, US · 2 510(k) clearances · 19 PMAs

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
2
2022-01-06 → 2022-08-02
Last 12 months
0
Product codes
2
Most recent
2022-08-02
Name variants in FDA filings: Glaukos / Glaukos Corporation
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KYF Implant, Eye Valve Class II Ophthalmic 1 2022-08-02
MRH — — — 1 2022-01-06
Class III

PMA approvals (19)

Total PMA records
19
Originals + supplements
Distinct product codes
1
First decision
2020-04-30
Most recent
2026-04-08
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-04-08 P080030-S027 iStent® Trabecular Micro-Bypass Stent System Real-Time Process OGO Intraocular Pressure Lowering Implant Unknown
2025-02-24 P170043-S019 iStent inject® W Trabecular Micro-Bypass System Model iS2 Normal 180 Day Track OGO Intraocular Pressure Lowering Implant Unknown
2025-01-13 P170043-S020 iStent inject Trabecular MicroBypass System Normal 180 Day Track No User Fee OGO Intraocular Pressure Lowering Implant Unknown
2024-03-28 P080030-S026 iStent® Trabecular Mjcro-Bypass Stent System, Model GTS100 Normal 180 Day Track No User Fee OGO Intraocular Pressure Lowering Implant Unknown
2023-12-20 P170043-S018 Glaukos® Corporation iStent inject® W Trabecular Micro-Bypass System 135 Review Track For 30-Day Notice OGO Intraocular Pressure Lowering Implant Unknown
2023-07-14 P170043-S017 iStent inject® W Trabecular Micro-Bypass System 30-Day Notice OGO Intraocular Pressure Lowering Implant Unknown
2023-07-13 P170043-S016 iStent inject® W Trabecular Micro-Bypass System 30-Day Notice OGO Intraocular Pressure Lowering Implant Unknown
2022-11-07 P170043-S013 iStent inject W Trabecular Micro-Bypass System 135 Review Track For 30-Day Notice OGO Intraocular Pressure Lowering Implant Unknown
2022-08-29 P170043-S014 iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi Normal 180 Day Track OGO Intraocular Pressure Lowering Implant Unknown
2022-08-29 P080030-S024 iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi Normal 180 Day Track OGO Intraocular Pressure Lowering Implant Unknown
2022-02-18 P170043-S012 iStent inject® Trabecular Micro-Bypass System Model 30-Day Notice OGO Intraocular Pressure Lowering Implant Unknown
2022-02-18 P080030-S023 iStent® Trabecular Micro-Bypass Stent System 30-Day Notice OGO Intraocular Pressure Lowering Implant Unknown
2021-09-10 P170043-S010 iStent inject W Trabecular Micro-Bypass System Normal 180 Day Track OGO Intraocular Pressure Lowering Implant Unknown
2021-08-31 P170043-S009 iStent inject W Trabecular Micro-Bypass System 135 Review Track For 30-Day Notice OGO Intraocular Pressure Lowering Implant Unknown
2021-03-03 P170043-S008 iStent inject Trabecular Micro-Bypass System Normal 180 Day Track No User Fee OGO Intraocular Pressure Lowering Implant Unknown
2020-07-02 P170043-S005 iStent inject W Trabecular Micro-Bypass System Normal 180 Day Track OGO Intraocular Pressure Lowering Implant Unknown
2020-06-01 P170043-S003 iStent inject Trabecular Micro-Bypass System Normal 180 Day Track OGO Intraocular Pressure Lowering Implant Unknown
2020-04-30 P170043-S007 iStent inject Trabecular Micro-Bypass System Normal 180 Day Track No User Fee OGO Intraocular Pressure Lowering Implant Unknown
2020-04-30 P170043-S006 iStent inject Trabecular Micro-Bypass System Normal 180 Day Track No User Fee OGO Intraocular Pressure Lowering Implant Unknown
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2022-08-02 K220032 iStent infinite Trabecular Micro-Bypass System, Model iS3 KYF Class II Ophthalmic
2022-01-06 K212797 iPrime Viscodelivery System MRH — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence