Phakosystems, Inc.
Country not established
- Devices
- 5
What Phakosystems, Inc. makes
Phakosystems, Inc. manufactures ophthalmic surgical systems, including irrigation-aspiration units like the Model 1000/OMNI Packs, ultrasound probes such as the Vision Care/Echopach and EchoruLe, and cataract surgery accessories like the Model CES 4100. The company also produces cautery modules, including the CT-100, designed for precision tissue management during eye procedures.
These devices are classified under FDA regulations as Class I and Class II, with most requiring 510(k) clearance. The products are listed in the FDA’s 510(k) database, and the company is headquartered in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Vision Care/Phakosystems Echopach Ref K880081
Regimes: 510(k) Registry: 510(k)Vision Care/Phakosystems Echorule Ref K871938
Regimes: 510(k) Registry: 510(k)Phakosystems Model Ces 4100 Ref K851674
Regimes: 510(k) Registry: 510(k)Phakosystems Ct-100 Cautery Module Ref K860236
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Phakosystems, Inc. have in the registry?
The registry currently lists 5 devices for Phakosystems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Phakosystems, Inc.'s devices?
Among its 5 most recently registered devices, Phakosystems, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Phakosystems, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Phakosystems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Phakosystems, Inc. in the registry?
The most recently registered devices listed for Phakosystems, Inc. include PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION, VISION CARE/PHAKOSYSTEMS ECHOPACH, VISION CARE/PHAKOSYSTEMS ECHORULE and PHAKOSYSTEMS MODEL CES 4100.