Leadoptik Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3042970803
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
- Registry: GUDID
LIA-1 Catheter (542-1) Ref K251402
Regimes: 510(k) Registry: 510(k)LIA Console (542-7) Ref K251730
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3042970803
- Address
- 2380 Qume Dr Ste A, San Jose, CA, 95131
Frequently asked questions
How many devices does LEADOPTIK INC. have in the registry?
The registry currently lists 3 devices for LEADOPTIK INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list LEADOPTIK INC.'s devices?
Among its 3 most recently registered devices, LEADOPTIK INC. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do LEADOPTIK INC.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for LEADOPTIK INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from LEADOPTIK INC. in the registry?
The most recently registered devices listed for LEADOPTIK INC. include LIA Console 542-7, LIA-1 Catheter (542-1) and LIA Console (542-7).