Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 2 companies' records, each linked to the record.
As of Nov 13, 2026, FDA's public records list Lumibird and its 2 subsidiaries with 46 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Feb 6, 2026: INTEGRE LIO.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Lumibird and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 6, 2026 | INTEGRE LIOK251507 · HQF | 510(k) clearances |
| Apr 26, 2024 | Pocket IIIK232302 · IYO | 510(k) clearances |
| 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 |
| May 12, 2022 | CapsuloK220430 · HQF | 510(k) clearances |
| Dec 16, 2021 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, SoloK212630 · HQF | 510(k) clearances |
| Nov 15, 2021 | Axialis Ophthalmic Ultrasound SystemK213254 · IYO | 510(k) clearances |
| Aug 6, 2020 | Vitra 810K201502 · HQF | 510(k) clearances |
| Dec 5, 2019 | Vitra 2K191962 · 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
