Soflex Limited
Country not established
- Devices
- 3
What Soflex Limited makes
Soflex Limited manufactures soft hydrophilic contact lenses designed for daily wear, including toric and multifocal variants for vision correction. Their portfolio includes lenses for keratoconus and irregular corneal conditions, such as semi-scleral and toric soft K lenses. The company also produces standard spherical soft contact lenses.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Soflex Limited have in the registry?
The registry currently lists 3 devices for Soflex Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Soflex Limited's devices?
Among its 3 most recently registered devices, Soflex Limited has devices listed in FDA 510(k) (3 devices).
What risk classes do Soflex Limited's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Soflex Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Soflex Limited in the registry?
The most recently registered devices listed for Soflex Limited include ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS, ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S and ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR.