Fluoptics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K230898FLUOBEAM® LX RedJuly 28, 2023
K190891Fluobeam LXJuly 31, 2019
DEN170092Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control SystemNovember 2, 2018
K132475FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEMMay 7, 2014