Rose K International, Ltd.
New ZealandFDA applicant, unverified
- Devices
- 2
What Rose K International, Ltd. makes
Rose K International, Ltd. manufactures intraocular lenses, including the ROSE K LENS and ROSE K POST GRAFT LENS, designed for ocular implantation.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Rose K Lens Ref K945955
Regimes: 510(k) Registry: 510(k)Rose K Post Graft Lens Ref K013646
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rose K International, Ltd. have in the registry?
The registry currently lists 2 devices for Rose K International, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rose K International, Ltd.'s devices?
Among its 2 most recently registered devices, Rose K International, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Rose K International, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Rose K International, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rose K International, Ltd. in the registry?
The most recently registered devices listed for Rose K International, Ltd. include ROSE K LENS and ROSE K POST GRAFT LENS.