Eclipsemed Global, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Eclipsemed Global, Inc. makes
Eclipsemed Global, Inc. manufactures the FUSION SYSTEM, a medical device designed for surgical applications, and the EQUINOX CO2 LASER SYSTEM, used for precision laser procedures in clinical settings.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Fusion System Ref K093465
Regimes: 510(k) Registry: 510(k)Equinox CO2 Laser System Ref K100487
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Eclipsemed Global, Inc. have in the registry?
The registry currently lists 2 devices for Eclipsemed Global, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eclipsemed Global, Inc.'s devices?
Among its 2 most recently registered devices, Eclipsemed Global, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Eclipsemed Global, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Eclipsemed Global, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Eclipsemed Global, Inc. in the registry?
The most recently registered devices listed for Eclipsemed Global, Inc. include FUSION SYSTEM and EQUINOX CO2 LASER SYSTEM.