Data / Medical devices / Italy / Safilens S.R.L.
Safilens S.R.L.: FDA-registered device maker in Staranzano Gorizia, Italy, 1 510(k) clearance
Safilens S.R.L. is registered with the FDA (registration 3006405660) in Staranzano Gorizia, Italy. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 18, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006405660
- Address
- Via Maria Grazia Deledda, 5, Staranzano Gorizia, Italy, 34079
- Owner or operator
- Safilens S.r.l. (10031920)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- March 22, 2010
- Registered through
- 2026
- Brand names listed
- SafeGel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 18, 2009 | K090806 | SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON | LPL | Substantially Equivalent | Safilens, S.R.L. | accessdata.fda.gov |
Compare with other makers
Updated December 18, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.