Iridex Corp: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Iridex Corp” (first 1998, latest 2023), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 79 days. Since 2017 the median was 46 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 194 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 60 |
| 2016 | 1 | 30 |
| 2017 | 1 | 55 |
| 2018 | 1 | 72 |
| 2019 | 0 | — |
| 2020 | 1 | 30 |
| 2021 | 0 | — |
| 2022 | 2 | 84 |
| 2023 | 1 | 27 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Iridex Corp took a median 46 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 14 | 14 |
| HQF | Laser, Ophthalmic | 8 | 8 |
Review panels
Most recent Iridex Corp 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | HQF | 2023-02-23 | 27 |
| K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | HQF | 2022-11-09 | 37 |
| K213592 | Iridex 810 Laser | HQF | 2022-03-23 | 131 |
| K202760 | Iridex 810 Laser | HQF | 2020-10-21 | 30 |
| K181662 | Iridex TruFocus LIO Premiere | GEX | 2018-09-05 | 72 |
| K170718 | Iridex TruFocus LIO Premiere | GEX | 2017-05-03 | 55 |
| K162416 | IRIDEX Cyclo G6 Laser System, G-Probe Illuminate | GEX | 2016-09-29 | 30 |
| K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) | GEX | 2015-01-02 | 60 |
| K121475 | TXCELL SCANNING LASER DELIVERY SYSTEM | GEX | 2012-11-28 | 194 |
| K071687 | FAMILI OF IRIDEX IQ LASER SYSTEMS | GEX | 2008-08-07 | 416 |
12 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-02-27.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
IRIDEX CORP (IRIX): EDGAR filings, CIK 1006045. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Iridex Corp?
FDA lists 22 510(k) clearances under the applicant name “Iridex Corp” (first 1998, latest 2023), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Iridex Corp?
The median time from FDA receipt to decision across 510(k)s cleared under the name Iridex Corp is 79 days. Since 2017: 46 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Iridex Corp?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 14); HQF (Laser, Ophthalmic, 8).
Next steps
- See all 22 Iridex Corp clearances with predicates and recalls
- Run predicate analysis for product code GEX, Iridex Corp's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.