Safilens, S.R.L.
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Safilens, S.R.L. makes
Safilens, S.R.L. manufactures daily disposable soft contact lenses, including standard and toric variants made from methafilcon A hydrogel. These products are designed for single-use wear and are intended to correct vision or address astigmatism.
The company’s portfolio is classified under FDA Class II devices and is listed via the 510(k) pathway in the United States. The products are regulated under US medical device laws, with compliance managed through the FDA’s premarket notification process.
Catalogue
- 510(k) 510(k)
FDA establishments
- Safilens S.R.L. Staranzano Gorizia · IT FEI 3006405660
Frequently asked questions
How many devices does Safilens, S.R.L. have in the registry?
The registry currently lists 1 device for Safilens, S.R.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Safilens, S.R.L.'s devices?
Among its 1 most recently registered device, Safilens, S.R.L. has devices listed in FDA 510(k) (1 device).
What risk classes do Safilens, S.R.L.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Safilens, S.R.L.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Safilens, S.R.L. in the registry?
The most recently registered devices listed for Safilens, S.R.L. include SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON.
Which FDA establishments are linked to Safilens, S.R.L.?
1 FDA establishment is linked to Safilens, S.R.L. in the registry; they are listed on the company page.