Data / Medical devices / United States / Illuminoss Medical Inc.
Illuminoss Medical Inc.: FDA-registered device maker in East Providence, RI, United States, 1 510(k) clearance
Illuminoss Medical Inc. is registered with the FDA (registration 3006845464) in East Providence, RI, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 19, 2017. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3006845464
- Address
- 993 Waterman Ave, East Providence, RI, United States, 02914
- Owner or operator
- IlluminOss Medical Inc. (10035738)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- March 21, 2011
- Registered through
- 2027
- Brand names listed
- IlluminOss Photodynamic Bone Stabilization System, Photodynamic Bone Stabilization System (US-IDE, EU-CE)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Manufacturer for export | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated | QAD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 19, 2017 | DEN160062 | IlluminOss Bone Stabilization System | QAD | Unknown | Illminoss Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 19, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.