Laserex Systems Inc.

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-2172-2017Class IIEllex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to beApril 4, 2017
Z-1270-2016Class IIEllex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binoFebruary 1, 2016