FDA Registration
Active
🇺🇸 United States
STAAR Surgical Company
Reg #: 3014173684
·
FEI: 3014173684
·
Expires 2026
Products
6
Proprietary Names
14
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- STAAR Surgical Company
- Registration Number
- 3014173684
- FEI Number
- 3014173684
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 15102 Red Hill Avenue
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
Regulatory Submissions
- 510(k) Number
- K073586
- PMA Number
- P030016
Owner / Operator
- Firm Name
- STAAR SURGICAL Company
- Operator Number
- 2023826
- Address
- 1911 WALKER AVE., --
- City
- Monrovia
- State
- CA
- Postal Code
- 91016
- Country
- US
- Correspondent
- Magda Michna
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Phakic Toric Intraocular Lens | QCB | Class 3 | Ophthalmic | No | 2007-11-12 |
| Lens, Intraocular, Phakic | MTA | Class 3 | Unknown | No | 2007-11-12 |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2008-10-28 |
| Lens, Guide, Intraocular | KYB | Class 1 | Ophthalmic | No | 2016-12-19 |
| Lens, Intraocular, Toric Optics | MJP | Class 3 | Ophthalmic | No | 1992-10-22 |
| Intraocular Lens | HQL | Class 3 | Ophthalmic | No | 1992-10-22 |
Proprietary Names
EVO+ VISIAN Implantable Collamer Lens
EVO+ VISIAN Toric Implantable Collamer Lens
EVO VISIAN Toric Implantable Collamer Lens
EVO VISIAN Implantable Collamer Lens
Implantable Collamer Lens
MICROSTAAR
Elastimide UVA PC Toric IOL
Elastimide UVA PC Intraocular Lens
Elastic UVA PC Intraocular Lens
MicroSTAAR Injector System (TM/PM)
MicroSTAAR Injector System (TD/PD)
MicroSTAAR Injector System (TF/PF)
Epiphany
Collamer UVA PC Introcular Lens
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility