Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Iridex Corporation — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
131 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and | Iridex Corporation | 2023-02-23 | 27 | 0 |
| K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532n | Iridex Corporation | 2022-11-09 | 37 | 0 |
| K213592 | Iridex 810 Laser | Iridex Corporation | 2022-03-23 | 131 | 0 |
| K202760 | Iridex 810 Laser | Iridex Corporation | 2020-10-21 | 30 | 0 |
| K181662 | Iridex TruFocus LIO Premiere | Iridex Corporation | 2018-09-05 | 72 | 0 |
| K170718 | Iridex TruFocus LIO Premiere | Iridex Corporation | 2017-05-03 | 55 | 0 |
| K162416 | IRIDEX Cyclo G6 Laser System, G-Probe Illuminate | Iridex Corporation | 2016-09-29 | 30 | 0 |
| K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RF | Iridex Corporation | 2015-01-02 | 60 | 0 |
| K041930 | VARILITE LASER SYSTEM | Iridex Corporation | 2004-09-10 | 53 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda