Lumenis Limited

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0301-2017Class IIFemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) September 25, 2016
Z-1519-2015Class IILight Sheer Desire Diode Laser System with XC Handpiece Accessory options.March 25, 2015
Z-0795-2013Class IThe Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endJanuary 2, 2013