Data / Medical devices / Israel / Illumigyn Ltd.
Illumigyn Ltd.: FDA-registered device maker in Neve Ilan Central, Israel, 1 510(k) clearance
Illumigyn Ltd. is registered with the FDA (registration 3016250458) in Neve Ilan Central, Israel. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 8, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016250458
- Address
- Communication Center Neve Ilan, Neve Ilan Central, Israel, 9085000
- Owner or operator
- Illumigyn Ltd. (10062009)
- Roles
- Manufacturer
- First device listed
- December 11, 2019
- Registered through
- 2026
- Brand names listed
- Gynescope System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colposcope (And Colpomicroscope) | HEX | 2 | Manufacturer | accessdata.fda.gov |
| Speculum, Vaginal, Nonmetal | HIB | 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 |
|---|---|---|---|---|---|---|
| May 8, 2019 | K190187 | Gynescope System | HEX | Substantially Equivalent | Illumigyn , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 8, 2019. 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.