FDA Registration
Active
🇺🇸 United States
iStent inject Trabecular Micro-Bypass System, Model G2-M-IS
Reg #: 3012833022
·
FEI: 3012341472
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Glaukos Corporation
- Registration Number
- 3012833022
- FEI Number
- 3012341472
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 229 Avenida Fabricante
- City
- San Clemente
- State
- CA
- ZIP
- 92672
- Country
- US
Regulatory Submissions
- PMA Number
- P170043
Owner / Operator
- Firm Name
- GLAUKOS CORP.
- Operator Number
- 9050364
- Address
- One Glaukos Way, --
- City
- Aliso Viejo
- State
- CA
- Postal Code
- 92656
- Country
- US
- Correspondent
- David - Fernquist
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intraocular Pressure Lowering Implant | OGO | Class 3 | Unknown | No | 2018-06-22 |
Proprietary Names
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
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device