GLAUKOS CORPORATION

GLAUKOS CORPORATION

Address:229 Avenida Fabricante,San Clemente,CA,92672,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Intraocular Pressure Lowering Implant (OGO) (5) Implant, Eye Valve (KYF) (2) Pump, Infusion, Ophthalmic (MRH) (1) Trephine, Manual, Ophthalmic (HRH) (1)

Premarket Exempt

No Yes

Clear

iStent - 00853704002005 Catalog Number : GTS100R

Device Description : Trabecular Micro-bypass Stent System - Right

Device Class : 3

Duns Number: 012835406

Premarket Exempt : No

Product Code : OGO

Prescription Use : Yes

Device Count : 1

iStent - 00853704002012 Catalog Number : GTS100L

Device Description : Trabecular Micro-bypass stent system - Left

Device Class : 3

Duns Number: 012835406

Premarket Exempt : No

Product Code : OGO

Prescription Use : Yes

Device Count : 1

iStent - 00853704002029 Catalog Number : GTS100i

Device Description : Trabecular Micro-bypass Inserter

Device Class : 3

Duns Number: 012835406

Premarket Exempt : No

Product Code : OGO

Prescription Use : Yes

Device Count : 1

iStent inject - 00853704002203 Catalog Number : G2-M-IS

Device Description : Trabecular Micro-Bypass System

Device Class : 3

Duns Number: 012835406

Premarket Exempt : No

Product Code : OGO

Prescription Use : Yes

Device Count : 1

iStent inject W - 00853704002319 Catalog Number : G2-W

Device Description : Trabecular Micro-Bypass System

Device Class : 3

Duns Number: 012835406

Premarket Exempt : No

Product Code : OGO

Prescription Use : Yes

Device Count : 1

iStent Infinite - 00853704002449 Catalog Number : iS3-US

Device Description : Trabecular Micro-Bypass System

Device Class : 2

Duns Number: 012835406

Premarket Exempt : No

Product Code : KYF

Prescription Use : Yes

Device Count : 1

iPRIME - 00853704002456 Catalog Number : VCP100

Device Description : Viscodelivery System

Device Class : 2

Duns Number: 012835406

Premarket Exempt : No

Product Code : MRH

Prescription Use : Yes

Device Count : 1

iAccess - 00853704002463 Catalog Number : AX1

Device Description : Trabecular Trephine

Device Class : 1

Duns Number: 012835406

Premarket Exempt : Yes

Product Code : HRH

Prescription Use : Yes

Device Count : 1

iStent infinite - 00853704002470 Catalog Number : iS3

Device Description : Trabecular Micro-Bypass System

Device Class : 2

Duns Number: 012835406

Premarket Exempt : No

Product Code : KYF

Prescription Use : Yes

Device Count : 1

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