Stargate International, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Stargate International, Inc. makes
Stargate International, Inc. manufactures light therapy systems, including the Quantum Light Therapy System and the Excaliber series (models SGIEX-04-001 and SGEX4-001), designed for medical applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Quantum Light Therapy System Ref K032816
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stargate International, Inc. have in the registry?
The registry currently lists 3 devices for Stargate International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stargate International, Inc.'s devices?
Among its 3 most recently registered devices, Stargate International, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Stargate International, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Stargate International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stargate International, Inc. in the registry?
The most recently registered devices listed for Stargate International, Inc. include QUANTUM LIGHT THERAPY SYSTEM, EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 and EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001.