Premier Dynamics, Inc.
Country not established
- Devices
- 1
What Premier Dynamics, Inc. makes
Premier Dynamics, Inc. manufactures the SPECTRA THERAPY SYSTEM A1000, a Class II laser device designed for therapeutic applications.
The company’s portfolio is regulated under FDA’s 510(k) pathway as a Class II device and is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Spectra Therapy System A1000 Laser Device Ref K080689
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Premier Dynamics, Inc. have in the registry?
The registry currently lists 1 device for Premier Dynamics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Premier Dynamics, Inc.'s devices?
Among its 1 most recently registered device, Premier Dynamics, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Premier Dynamics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Premier Dynamics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Premier Dynamics, Inc. in the registry?
The most recently registered devices listed for Premier Dynamics, Inc. include SPECTRA THERAPY SYSTEM A1000 LASER DEVICE.