Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in AustraliaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of LumibirdLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Ellex Medical with 13 510(k) clearances and 1 device recall. The most recent is a device recall dated Mar 16, 2023: Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre….
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.
| Mar 16, 2023 | Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6GClass II · When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity | Device recalls |
| Nov 2, 2022 | Tango Neo, Tango Reflex Neo, Ultra Q Reflex NeoK222395 · HQF | 510(k) clearances |
| Dec 16, 2021 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, SoloK212630 · HQF | 510(k) clearances |
| Apr 11, 2019 | Eye PrimeK190786 · IYO | 510(k) clearances |
| Jul 14, 2015 | Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-YellowK142398 · HQF | 510(k) clearances |
| Jul 1, 2013 | ELLEX 2RTK122202 · HQF | 510(k) clearances |
| Jul 2, 2008 | INTEGRE PRO, MODEL L2RYK081565 · HQF | 510(k) clearances |
| Mar 11, 2008 | INTEGRE, MODEL LP581K080423 · HQF | 510(k) clearances |
| Mar 16, 2006 | LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-DK052777 · GEX | 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
