Lumenis Limited
Lumenis Limited appears in FDA public data with 3 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0301-2017, Class II) was initiated on September 25, 2016.
Summary
- Total Recalls
- 3 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0301-2017 | Class II | FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) | September 25, 2016 |
| Z-1519-2015 | Class II | Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. | March 25, 2015 |
| Z-0795-2013 | Class I | The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or end | January 2, 2013 |