Ophtec, USA
Also registered as Ophtec USA, Inc.
Country not established
- Devices
- 2
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Easy Control Micro Inserter, Model ON385 Ref K011498
Regimes: 510(k) Registry: 510(k)Ophtec Enclavation Needle Ref K030471
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ophtec, USA have in the registry?
The registry currently lists 2 devices for Ophtec, USA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ophtec, USA's devices?
Among its 2 most recently registered devices, Ophtec, USA has devices listed in FDA 510(k) (2 devices).
What risk classes do Ophtec, USA's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ophtec, USA's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ophtec, USA in the registry?
The most recently registered devices listed for Ophtec, USA include EASY CONTROL MICRO INSERTER, MODEL ON385 and OPHTEC ENCLAVATION NEEDLE.