Illuminoss Medical, Inc.
Illuminoss Medical, Inc. appears in FDA public data with 0 recalls, 6 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Feb 1, 2024 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Jan 19, 2024.
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Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 4
- Compliance Actions
- 0
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 1, 2024 | East Providence, RI | Devices | No Action Indicated (NAI) | 3006845464 |
| Nov 2, 2022 | East Providence, RI | Devices | Voluntary Action Indicated (VAI) | 3006845464 |
| Sep 24, 2019 | East Providence, RI | Devices | Voluntary Action Indicated (VAI) | 3006845464 |
| Aug 31, 2016 | East Providence, RI | Devices | Voluntary Action Indicated (VAI) | 3006845464 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K233436 | IlluminOss Photodynamic Bone Stabilization System | Jan 19, 2024 |
| K202887 | IlluminOss Bone Stabilization System | Oct 27, 2020 |
| K201961 | IlluminOss Photodynamic Bone Stabilization System | Aug 13, 2020 |
| K200295 | IlluminOss Bone Stabilization System | Jun 25, 2020 |
| K183145 | IlluminOss Photodynamic Bone Stabilization System | Dec 13, 2018 |
| K181228 | IlluminOss Bone Stabilization System | Aug 31, 2018 |