Recall Z-1669-2016— Lumenis Ltd
Class II · Terminated
Class II FDA medical device recall by Lumenis Ltd, initiated 2015-11-17, terminated 2016-11-30. It names one FDA 510(k) clearance: K142860. Product: Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).. Reason: Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device..
- Recalling firm
- Lumenis Ltd
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-17
- Terminated
- 2016-11-30
- Firm location
- Yokneam, N/A, Israel
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
Reason for recall
Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.