Orlux Engineering and Instrumentation
CanadaFDA applicant, unverified
- Devices
- 2
What Orlux Engineering and Instrumentation makes
Orlux Engineering and Instrumentation manufactures endoscopic light sources, including the 250 ENDO model, and fiber optic light cables designed for medical imaging procedures. These devices provide illumination for flexible endoscopes to enhance visualization during examinations.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) premarket notifications. The portfolio is listed in the FDA 510(k) database, reflecting their regulatory authorization in the United States.
Catalogue
Endoscopic Light Source 250 Endo Ref K903790
Regimes: 510(k) Registry: 510(k)Fiber Optic Light Cable Ref K903800
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orlux Engineering and Instrumentation have in the registry?
The registry currently lists 2 devices for Orlux Engineering and Instrumentation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orlux Engineering and Instrumentation's devices?
Among its 2 most recently registered devices, Orlux Engineering and Instrumentation has devices listed in FDA 510(k) (2 devices).
What risk classes do Orlux Engineering and Instrumentation's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Orlux Engineering and Instrumentation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orlux Engineering and Instrumentation in the registry?
The most recently registered devices listed for Orlux Engineering and Instrumentation include ENDOSCOPIC LIGHT SOURCE 250 ENDO and FIBER OPTIC LIGHT CABLE.