Medkey, LLC
Country not established
- Devices
- 1
What Medkey, LLC makes
Medkey, LLC manufactures the DuraLaze™ HoLEP Laser Fiber, a device used for holmium laser enucleation of the prostate (HoLEP) procedures to treat benign prostatic hyperplasia (BPH).
The DuraLaze™ HoLEP Laser Fiber is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
DuraLazeTM HoLEP Laser Fiber Ref K153124
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medkey, LLC have in the registry?
The registry currently lists 1 device for Medkey, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medkey, LLC's devices?
Among its 1 most recently registered device, Medkey, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Medkey, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Medkey, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medkey, LLC in the registry?
The most recently registered devices listed for Medkey, LLC include DuraLazeTM HoLEP Laser Fiber.