Iriderm Div.: FDA clearances and approvals
Iriderm Div. has 10 FDA 510(k) clearances (first 1989, latest 1997), across 2 product codes in 2 review panels. Median 510(k) review time: 135 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 8 | 8 |
| HQF | Laser, Ophthalmic | 2 | 2 |
Review panels
Most recent Iriderm Div. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964074 | DIOLITE 532 | GEX | 1997-04-01 | 172 |
| K960971 | OCULIGHT GL | HQF | 1996-08-28 | 170 |
| K960522 | DIOPEXY PROBE | HQF | 1996-07-19 | 164 |
| K915236 | IRIS G-PROBE | GEX | 1994-07-28 | 979 |
| K933211 | D'AMICO\PEYMAN FLUTED ENDOPROBE | GEX | 1994-04-19 | 350 |
| K922663 | IRIS OCULIGHT SL | GEX | 1992-08-11 | 82 |
| K913430 | IRIS OCULIGHT(R) SLX | GEX | 1991-11-15 | 106 |
| K912918 | IRIS OCULIGHT DIODE LASER ADDING SLIT LAMP ADAPTER | GEX | 1991-08-23 | 51 |
| K903288 | IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED | GEX | 1990-09-24 | 88 |
| K894841 | IRIS OCULIGHT(TM) SL | GEX | 1989-10-05 | 66 |
Recalls
openFDA lists no recalls under a recalling firm named Iriderm Div..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Iriderm Div. have?
Iriderm Div. has 10 FDA 510(k) clearances (first 1989, latest 1997), across 2 product codes in 2 review panels.
How long does FDA take to clear Iriderm Div.'s 510(k)s?
The median time from FDA receipt to decision across Iriderm Div.'s cleared 510(k)s is 135 days.
What devices does Iriderm Div. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 8); HQF (Laser, Ophthalmic, 2).
Has Iriderm Div. had device recalls?
openFDA lists no recalls under a recalling firm name matching Iriderm Div. Related entities may recall under other names.
Next steps
- See all 10 Iriderm Div. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Iriderm Div.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.