Isolux America
Country not established
- Devices
- 3
What Isolux America makes
Isolux America manufactures endoscopic fiberoptic cables and surgical headlights, including xenon fiberoptic light sources like the Model 1300 XSBP. These products are designed for use in medical procedures requiring high-intensity illumination, such as minimally invasive surgeries and endoscopic examinations.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) registry, adhering to US medical device compliance standards. The manufacturer operates from the United States.
Catalogue
Endoscopic Fiberoptic Cable Ref K991208
Regimes: 510(k) Registry: 510(k)Isolux Surgical Headlight Ref K991572
Regimes: 510(k) Registry: 510(k)Xenon Fiberoptic Light Source, Model 1300 Xsbp Ref K022384
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Isolux America have in the registry?
The registry currently lists 3 devices for Isolux America. Devices recorded under merged duplicate company entries are counted once.
Which registries list Isolux America's devices?
Among its 3 most recently registered devices, Isolux America has devices listed in FDA 510(k) (3 devices).
What risk classes do Isolux America's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Isolux America's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Isolux America in the registry?
The most recently registered devices listed for Isolux America include ENDOSCOPIC FIBEROPTIC CABLE, ISOLUX SURGICAL HEADLIGHT and XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP.