FDA Registration
Active
🇩🇪 Germany
OCULUS OPTIKGERATE GMBH
Reg #: 9611269
·
FEI: 3002807782
·
Expires 2026
Products
23
Proprietary Names
49
Establishment Types
1
Classifications
23
Registration Details
- Registration Name
- OCULUS OPTIKGERATE GMBH
- Registration Number
- 9611269
- FEI Number
- 3002807782
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- MUNCHHOLZHAUSER STR. 29
- City
- WETZLAR Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K113066
Owner / Operator
- Firm Name
- OCULUS OPTIKGERATE GMBH
- Operator Number
- 8010318
- Address
- Muenchholzhaeuser Str. 29, --
- City
- WETZLAR
- State
- DE-NOTA
- Postal Code
- D-35582
- Country
- DE
US Agent
- Business Name
- OCULUS Surgical, Inc
- Contact Name
- Michael Krakowiecki
- Address
- 562 NW Mercantile Place
- City
- Port Saint Lucie
- State
- FL
- ZIP
- 34986
- Country
- US
- [email protected]
- Phone
- 425 6709977
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Topographer, Corneal, Ac-Powered | MMQ | Class 1 | Ophthalmic | No | 2000-07-11 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | Class 1 | General, Plastic Surgery | No | 2004-04-26 |
| Table, Instrument, Powered, Ophthalmic | HRJ | Class 1 | Ophthalmic | No | 2013-09-07 |
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2012-12-19 |
| Device, Analysis, Anterior Segment | MXK | Class 2 | Ophthalmic | No | 2012-12-19 |
| Tester, Color Vision | HIT | Class 1 | Ophthalmic | No | 2011-08-26 |
| Set, Lens, Trial, Ophthalmic | HPC | Class 1 | Ophthalmic | No | 1978-04-20 |
| Spectacle, Operating (Loupe), Ophthalmic | HOH | Class 1 | Ophthalmic | No | 1986-06-09 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2013-08-27 |
| Exophthalmometer | HLS | Class 1 | Ophthalmic | No | 1978-04-20 |
| Perimeter, Ac-Powered | HOO | Class 1 | Ophthalmic | No | 1978-04-20 |
| Lens, Bagolini | HPD | Class 1 | Ophthalmic | No | 1978-04-20 |
| Perimeter, Automatic, Ac-Powered | HPT | Class 1 | Ophthalmic | No | 2000-07-11 |
| Pupillometer, Ac-Powered | HLG | Class 1 | Ophthalmic | No | 2016-09-05 |
| Stereoscope, Ac-Powered | HJQ | Class 1 | Ophthalmic | No | 2013-09-07 |
| Frame, Trial, Ophthalmic | HPA | Class 1 | Ophthalmic | No | 1978-04-20 |
| Tomography, Optical Coherence | OBO | Class 2 | Ophthalmic | No | 2026-03-25 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2020-11-06 |
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 1978-04-20 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 1978-04-20 |
| Anomaloscope | HIW | Class 1 | Ophthalmic | No | 2011-08-16 |
| Prism, Gonioscopic | HKS | Class 1 | Ophthalmic | No | 2023-03-22 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2020-11-09 |
Proprietary Names
Keratograph 5M
Easygraph
Keratograph
BINOCULAR INDIRECT OPHTHALMO MICROS
STEREO DIAGNOSTIC INVERTER
SDI 4
BIOM 6
BIOM 5
Hubtische
Ophthalmic table
Corvis STL
Color Vision Tester
C-Quant
Set, Lens, Trial
BIOM 6 Optic Set
Versa HD Disposable LenZ
Lens Ophthalmic, Reduction lens, Optic Set HD
HD Disposable LenZ
BIOM Optic Set
Lens Set for HAAG-STREIT EIBOS 2 & Leica RUV800
BIOM ready
BIOM Versa Optic Set
BIOM ready+
ImageCam 3
Pentacam
Pentacan HR
Exophthalmometer
Pentacam AXL
Easyfield C
Easyfield S
Smartfield
Centerfield 2
Twinfield 3
Lens, Bagolini
Perimeter
Myopia Master
Vissard 3D, Vissard MOBIL
Vissard RG
Binoptometer
Binoptometer 4P
Frame, Trial, Ophthalmic
Pentacam Cornea OCT
Pentacam AXL Wave
MAGNIFYING SPECTACLE
Chart, Visual Acuity
Anomaloscope
GONIO ready
GONIO ready CL
LidStick
Establishment Types
Manufacture Medical Device