Lumea, Inc.
Country not established
- Devices
- 1
What Lumea, Inc. makes
Lumea, Inc. manufactures the Viewer+, a medical imaging device designed for intraoperative visualization, enabling real-time assessment of tissue during surgical procedures.
The Viewer+ is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is headquartered in the United States.
Catalogue
Viewer+ Ref K242244
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lumea, Inc. have in the registry?
The registry currently lists 1 device for Lumea, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lumea, Inc.'s devices?
Among its 1 most recently registered device, Lumea, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Lumea, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Lumea, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lumea, Inc. in the registry?
The most recently registered devices listed for Lumea, Inc. include Viewer+.