Data / Medical devices / Israel / Eyeyon Medical
Eyeyon Medical: FDA-registered device maker in Nes Ziona Central, Israel, 1 510(k) clearance
Eyeyon Medical is registered with the FDA (registration 3012590738) in Nes Ziona Central, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 8, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012590738
- Address
- Golda Meir St 3 Floor 6, Nes Ziona Central, Israel, 7403648
- Owner or operator
- EyeYon Medical (10051953)
- Roles
- Specification developer
- First device listed
- May 24, 2016
- Registered through
- 2026
- Brand names listed
- EyeYon, Hyper-CL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lenses, Soft Contact, Daily Wear | LPL | 2 | 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 |
|---|---|---|---|---|---|---|
| April 8, 2016 | K153305 | EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear | LPL | Substantially Equivalent | Eyeyon Medical | accessdata.fda.gov |
Compare with other makers
Updated April 8, 2016. 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.