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    LUMENIS LTD

    Manufacturer
    🇮🇱 Israel·2 Importers

    Lumenis Be LTD

    Manufacturer
    🇮🇱 Israel·4 Importers

    LUMENIS, LTD.

    FDA registration
    LUMENIS, LTD.·2 products·🇮🇱 Israel

    Lumenis Be Ltd

    FDA registration
    Lumenis Be Ltd·6 products·🇮🇱 Israel

    Lumenis M22 System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Lumenis Stellar M22

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LUMENIS PULSE 120H

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).

    FDA Enforcement
    Class II ·Terminated·Lumenis Ltd·May 25, 2016

    (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

    The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    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 Enforcement
    Class I ·Terminated·Lumenis Limited·February 20, 2013

    Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System 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 Enforcement
    Class II ·Terminated·Lumenis·September 23, 2015

    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

    FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.

    FDA Enforcement
    Class II ·Terminated·Lumenis Limited·November 2, 2016

    Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

    FDA Enforcement
    Class II ·Terminated·Lumenis Limited·May 6, 2015