Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Pollogen with 18 510(k) clearances. The most recent is a 510(k) clearance dated Oct 12, 2025: GENEO X ELITE.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 12, 2025 | GENEO X ELITEK242227 · PAY | 510(k) clearances |
| Sep 12, 2025 | Legend X PlatformK252576 · GEI | 510(k) clearances |
| Sep 10, 2025 | OptiLUV DeviceK250734 · PBX | 510(k) clearances |
| Nov 1, 2024 | Legend X Desktop SystemK243217 · GEI | 510(k) clearances |
| May 8, 2024 | Legend X Applicator VOK240999 · GEI | 510(k) clearances |
| May 7, 2024 | Geneo X EliteK233766 · PAY | 510(k) clearances |
| Oct 17, 2023 | Legend X PlatformK232903 · GEI | 510(k) clearances |
| May 4, 2023 | Pollogen STOP U Model UXV DeviceK220322 · PAY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
