Fluoptics
FDA Regulatory Profile
Fluoptics appears in FDA public data with 0 recalls, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Jul 28, 2023.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K230898 | FLUOBEAM® LX Red | Jul 28, 2023 |
| K190891 | Fluobeam LX | Jul 31, 2019 |
| DEN170092 | Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System | Nov 2, 2018 |
| K132475 | FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM | May 7, 2014 |