Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list IRIDEX Corporation with 22 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Feb 23, 2023: Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models).
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 |
|---|---|---|
| Feb 23, 2023 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)K230228 · HQF | 510(k) clearances |
| Nov 9, 2022 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)K223132 · HQF | 510(k) clearances |
| Mar 23, 2022 | Iridex 810 LaserK213592 · HQF | 510(k) clearances |
| Oct 21, 2020 | Iridex 810 LaserK202760 · HQF | 510(k) clearances |
| Sep 5, 2018 | Iridex TruFocus LIO PremiereK181662 · GEX | 510(k) clearances |
| Feb 27, 2018 | Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used witClass II · It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris bu | Device recalls |
| May 3, 2017 | Iridex TruFocus LIO PremiereK170718 · GEX | 510(k) clearances |
| Sep 29, 2016 | IRIDEX Cyclo G6 Laser System, G-Probe IlluminateK162416 · GEX | 510(k) clearances |
| Jan 2, 2015 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)K143154 · 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
