Visx, Incorporated
United StatesFDA applicant, unverified
- Devices
- 2
What Visx, Incorporated makes
Visx, Incorporated manufactures ophthalmic diagnostic devices, including the VISX CustomVue slit illuminator with a desktop charger and the WaveScan wavefront system. These tools are designed for corneal topography and wavefront aberrometry, supporting refractive surgery planning and evaluation.
The company’s products are regulated under FDA’s 510(k) clearance process, with devices classified as Class I and Class II. The WaveScan system is listed under the 510(k) pathway, while the slit illuminator falls under Class I general controls. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Wavescan Wavefront System Model Hs 1 Ref K000327
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Visx, Incorporated have in the registry?
The registry currently lists 2 devices for Visx, Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Visx, Incorporated's devices?
Among its 2 most recently registered devices, Visx, Incorporated has devices listed in FDA 510(k) (2 devices).
What risk classes do Visx, Incorporated's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Visx, Incorporated's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Visx, Incorporated in the registry?
The most recently registered devices listed for Visx, Incorporated include VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 and WAVESCAN WAVEFRONT SYSTEM MODEL HS 1.