BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Lumenis M22 System

    K Number: K142860 · Decision Jan 21, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    9
    Review Days
    112

    Basic Information

    Device Name
    Lumenis M22 System
    K Number
    K142860
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lumenis Ltd.
    Date Received
    October 1, 2014
    Decision Date
    January 21, 2015
    Product Code
    GEX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEX Powered Laser Surgical Instrument

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    Other Clearances by Lumenis Ltd.

    K Number Device Name
    DEN200028 Lumenis Stellar M22
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    K193500 Stellar M22 for Intense Pulsed Light (IPL) and Laser System
    K180597 AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO
    K170179 LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
    K170121 Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories