Xintec Corp

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0162-2020Class IIIOptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assemblyOctober 29, 2017
Z-2866-2017Class IIOptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; MJune 23, 2017