One
Country not established
- Devices
- 2
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
One Personal Lubricant (Water Based) Ref K110691
Regimes: 510(k) Registry: 510(k)One Personal Lubricant (Silicone) Ref K110690
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does One have in the registry?
The registry currently lists 2 devices for One. Devices recorded under merged duplicate company entries are counted once.
Which registries list One's devices?
Among its 2 most recently registered devices, One has devices listed in FDA 510(k) (2 devices).
What risk classes do One's devices fall under?
Among its 2 most recently registered devices, the classes recorded for One's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from One in the registry?
The most recently registered devices listed for One include ONE PERSONAL LUBRICANT (WATER BASED) and ONE PERSONAL LUBRICANT (SILICONE).