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Lumitex Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0923-2020Class IIGiraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M122496December 11, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K120820GIRAFFE BLUE SPOT PT LITEJune 8, 2012
K053568BILISOFT PHOTOTHERAPY SYSTEMApril 17, 2006
K912747LULMITEX NEONATAL TRANSILLUMINATORDecember 24, 1991