FDA Registration
Active
🇫🇷 France
LUNEAU TECHNOLOGY OPERATIONS
Reg #: 3009173773
·
FEI: 3009173773
·
Expires 2026
Products
12
Proprietary Names
27
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- LUNEAU TECHNOLOGY OPERATIONS
- Registration Number
- 3009173773
- FEI Number
- 3009173773
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 Rue Roger Bonnet
- City
- Pont-de-l'Arche Eure
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K143086
Owner / Operator
- Firm Name
- LUNEAU TECHNOLOGY OPERATIONS
- Operator Number
- 8020811
- Address
- 2 Rue Roger Bonnet
- City
- Pont-de-l'Arche
- State
- Eure
- Postal Code
- 27340
- Country
- FR
US Agent
- Business Name
- Visionix USA, Inc
- Contact Name
- Peter G Sparacio
- Address
- 160 Eisenhower Ln N
- City
- Lombard
- State
- IL
- ZIP
- 60148
- Country
- US
- [email protected]
- Phone
- 630 5090949
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Esthesiometer, Ocular | HJC | Class 1 | Ophthalmic | No | 2007-12-13 |
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2015-06-02 |
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 2009-12-30 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2007-12-12 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2015-05-21 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2007-12-13 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2021-05-20 |
| Prism, Bar, Ophthalmic | HKW | Class 1 | Ophthalmic | No | 1985-03-10 |
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2007-12-13 |
| Device, Analysis, Anterior Segment | MXK | Class 2 | Ophthalmic | No | 2017-04-25 |
| Rack, Skiascopic | HMH | Class 1 | Ophthalmic | No | 1984-10-08 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 2009-12-30 |
Proprietary Names
L12 Aesthesiometer
VX120
VX220
DNEye Scanner 2
DNEye Scanner 2+
VX118
VX120+
VX36
VX40
VX40 Pro
VX22
VX25
VX70
VX90
VX110
Nexy
VX610
Prisms bars
Prisms
DNEye Scanner 3
VX650
Sterile Tonometer Prisms L900
VX130
VX130+
L2 Skiascopy racks
EyeRefract
VX65
Establishment Types
Manufacture Medical Device