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LUMENIS, LTD.

3 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including a recall (Z-2344-2025)LUMENIS, LTD.2025-08-21
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses recall (Z-1290-2025)LUMENIS, LTD.2025-03-05
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-10 recall (Z-1669-2016)Lumenis Ltd2016-05-13

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