Laserex Systems Inc.

FDA Regulatory Profile

Laserex Systems Inc. appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2172-2017, Class II) was initiated on April 4, 2017.

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