Coopervision Surgical
Country not established
- Devices
- 3
What Coopervision Surgical makes
Coopervision Surgical manufactures surgical lighting systems, including xenon light sources and their associated accessories for operating room use. The company also produces electrosurgical units, such as the LEEP System 6000, designed for gynecological procedures, and ophthalmic solutions like Hyskon (32% Dextran 70), used in intraocular procedures.
The company’s portfolio includes devices classified as Class II and Class III under FDA regulations, with some products authorised via the 510(k) pathway and others through Premarket Approval (PMA). These devices are listed in the FDA’s regulatory databases, and the company is based in the United States.
Catalogue
Xenon Light Source And Accessories Ref K921390
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Hyskon (32% Dextran 70) Ref N17511
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Coopervision Surgical have in the registry?
The registry currently lists 3 devices for Coopervision Surgical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Coopervision Surgical's devices?
Among its 3 most recently registered devices, Coopervision Surgical has devices listed in FDA 510(k) (2 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Coopervision Surgical's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Coopervision Surgical's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Coopervision Surgical in the registry?
The most recently registered devices listed for Coopervision Surgical include XENON LIGHT SOURCE AND ACCESSORIES, LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR and HYSKON (32% DEXTRAN 70).