BEUDAMED
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    OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.

    FDA Enforcement
    Class II ·Ongoing·LUMENIS, LTD.·August 27, 2025

    (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 Enforcement
    Class II ·Ongoing·LUMENIS, LTD.·March 12, 2025