Illuminoss Medical, Inc.: FDA clearances and approvals
Illuminoss Medical, Inc. has 6 FDA 510(k) clearances (first 2018, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time: 64 days. Since 2017 its median was 64 days, against 64 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 4 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 2 | 72 |
| 2019 | 0 | — |
| 2020 | 3 | 30 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 98 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Illuminoss Medical, Inc.'s cleared 510(k)s took a median 64 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 64 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QAD | Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated | 6 | 6 |
Review panels
- Orthopedic (6)
Most recent Illuminoss Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233436 | IlluminOss Photodynamic Bone Stabilization System | QAD | 2024-01-19 | 98 |
| K202887 | IlluminOss Bone Stabilization System | QAD | 2020-10-27 | 29 |
| K201961 | IlluminOss Photodynamic Bone Stabilization System | QAD | 2020-08-13 | 30 |
| K200295 | IlluminOss Bone Stabilization System | QAD | 2020-06-25 | 141 |
| K183145 | IlluminOss Photodynamic Bone Stabilization System | QAD | 2018-12-13 | 30 |
| K181228 | IlluminOss Bone Stabilization System | QAD | 2018-08-31 | 115 |
Recalls
openFDA lists no recalls under a recalling firm named Illuminoss Medical, Inc..
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.
Device clinical trials
Illuminoss Medical, Inc. is the industry lead sponsor of 4 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05206981: Device Global Registry for the IlluminOss Bone Stabilization System (Recruiting, started 2021-06-11)
- NCT02338492: Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus (Completed, started 2015-03)
- NCT02373904: A Safety and Efficacy Study of the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease (Completed, started 2015-02)
- NCT00823251: IlluminOss Hand Fracture International Clinical Feasibility Study (Completed, started 2008-12)
Frequently asked questions
How many FDA 510(k) clearances does Illuminoss Medical, Inc. have?
Illuminoss Medical, Inc. has 6 FDA 510(k) clearances (first 2018, latest 2024), across 1 product code in 1 review panel.
How long does FDA take to clear Illuminoss Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Illuminoss Medical, Inc.'s cleared 510(k)s is 64 days. Since 2017: 64 days, versus 64 days for all cleared 510(k)s in the same product codes.
What devices does Illuminoss Medical, Inc. make?
Its most frequent FDA product codes are QAD (Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated, 6).
Has Illuminoss Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Illuminoss Medical, Inc. Related entities may recall under other names.
Next steps
- See all 6 Illuminoss Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QAD, Illuminoss Medical, Inc.'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.