Data / Medical devices / Israel / Optonol, Ltd
Optonol, Ltd: FDA-registered device maker in NEVE ILAN Central, Israel, 1 510(k) clearance
Optonol, Ltd is registered with the FDA (registration 3003701944) in NEVE ILAN Central, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 26, 2002. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003701944
- Address
- Communication Center, NEVE ILAN Central, Israel, 90850
- Owner or operator
- Alcon Laboratories, Inc. (1610287)
- Roles
- Manufacturer
- First device listed
- March 2, 2010
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implant, Eye Valve | KYF | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 26, 2002 | K012852 | EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS | KYF | Substantially Equivalent | Optonol, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 26, 2002. 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.