FDA Registration
Active
🇺🇸 United States
NIDEK INCORPORATED
Reg #: 2936921
·
FEI: 2936921
·
Expires 2026
Products
25
Proprietary Names
1
Establishment Types
1
Classifications
25
Registration Details
- Registration Name
- NIDEK INCORPORATED
- Registration Number
- 2936921
- FEI Number
- 2936921
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6601 Cascades Court, Suite 130
- City
- The Colony
- State
- TX
- ZIP
- 75056
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190198
- PMA Number
- P970053
Owner / Operator
- Firm Name
- NIDEK CO., LTD.
- Operator Number
- 8030392
- Address
- 34-14 MAEHAMA, HIROISHI-CHO, --
- City
- GAMAGORI, AICHI
- State
- JP-23
- Postal Code
- 4430038
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2019-04-03 |
| Perimeter, Automatic, Ac-Powered | HPT | Class 1 | Ophthalmic | No | 2019-04-03 |
| Pupillometer, Ac-Powered | HLG | Class 1 | Ophthalmic | No | 2014-09-04 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2007-10-22 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2007-10-22 |
| Microscope, Specular | NQE | Class 2 | Ophthalmic | No | 2013-12-19 |
| Table, Instrument, Powered, Ophthalmic | HRJ | Class 1 | Ophthalmic | No | 2002-08-20 |
| Keratoscope, Ac-Powered | HLQ | Class 1 | Ophthalmic | No | 1983-07-14 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2017-06-25 |
| Excimer Laser System | LZS | Class 3 | Unknown | No | 2007-02-23 |
| Device, Communications, Images, Ophthalmic | NFG | Class 1 | Radiology | No | 2012-05-14 |
| Device, Storage, Images, Ophthalmic | NFF | Class 1 | Radiology | No | 2012-05-14 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2009-12-28 |
| System, Image Management, Ophthalmic | NFJ | Class 2 | Radiology | No | 2018-07-20 |
| Tomography, Optical Coherence | OBO | Class 2 | Ophthalmic | No | 2018-07-20 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2018-07-20 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2002-08-20 |
| Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla | LXS | Class 2 | Ophthalmic | No | 2007-10-22 |
| Photocoagulator And Accessories | HQB | Class 2 | Ophthalmic | No | 2011-07-29 |
| Ophthalmoscope, Laser, Scanning | MYC | Class 2 | Ophthalmic | No | 2023-04-04 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2006-04-06 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2020-12-07 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 2002-08-20 |
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 2006-04-06 |
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2007-10-22 |
Proprietary Names
PERIMETER
Establishment Types
Manufacture Medical Device