5 results
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38ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by Lumenis, Ltd, 13 Hayetzira Street, Yokneam Industrial Park, Yokneam, Israel 20692
FDA Recall
Terminated
·Lumenis Inc.·Product code GEX·April 8, 2005
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
FDA Recall
Terminated
·Lumenis Ltd
13 Hayetzira St.,Yokneam Ind. Park
Yokneam Israel·Product code GEX·November 17, 2015
The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
FDA Recall
Terminated
·Lumenis Limited 13 Hayetzira St., Yokneam Ind. Park Yokneam Israel·Product code GCJ·January 2, 2013
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
FDA Recall
Open, Classified
·LUMENIS, LTD. Yokneam Ind. Park 6, Ha-Kidma Yokne'Am Ilit Israel·Product code GEX·January 23, 2025
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
FDA Recall
Open, Classified
·LUMENIS, LTD. Yokneam Ind. Park 6, Ha-Kidma Yokne'Am Ilit Israel·Product code GEX·July 22, 2025