Data / Medical devices / Israel / Belkin Vision Ltd.
Belkin Vision Ltd.: FDA-registered device maker in Yavne Central, Israel, 1 510(k) clearance
Belkin Vision Ltd. is registered with the FDA (registration 3027683457) in Yavne Central, Israel. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 8, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027683457
- Address
- 13 Gan Rave Blvd., Yavne Central, Israel, 8122214
- Owner or operator
- BELKIN Vision Ltd. (10091141)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 17, 2024
- Registered through
- 2026
- Brand names listed
- DSLT Treatment Pack, Eagle, Voyager DSLT, Voyager DSLT Treatment Pack
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Ophthalmic | HQF | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Specula, Ophthalmic | HNC | 1 | Repackager or relabeler | 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 8, 2023 | K230722 | Eagle device | HQF | Substantially Equivalent | Belkin Vision, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 8, 2023. 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.