Olympic Ophthalmics
Country not established
- Devices
- 2
What Olympic Ophthalmics makes
Olympic Ophthalmics manufactures the iTEAR100, a transcutaneous neurostimulator designed to stimulate the lacrimal nerve for the treatment of dry eye syndrome.
The company’s portfolio is regulated under FDA’s Class II device classification, with the iTEAR100 authorised via the 510(k) pathway. The device is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
iTEAR Neurostimulator Ref DEN190026
Regimes: De Novo Registry: De NovoiTEAR100 Neurostimulator Ref K213623
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Olympic Ophthalmics have in the registry?
The registry currently lists 2 devices for Olympic Ophthalmics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Olympic Ophthalmics's devices?
Among its 2 most recently registered devices, Olympic Ophthalmics has devices listed in FDA 510(k) (2 devices).
What risk classes do Olympic Ophthalmics's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Olympic Ophthalmics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Olympic Ophthalmics in the registry?
The most recently registered devices listed for Olympic Ophthalmics include iTEAR Neurostimulator and iTEAR100 Neurostimulator.