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510(k) Data Aggregation

    K Number
    K220877
    Device Name
    Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems
    Manufacturer
    Lumenis Be, Inc.
    Date Cleared
    2022-07-15

    (112 days)

    Product Code
    HQF, GEX, HOF
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lumenis Be, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    · Selecta Duet LED or Digital Duet: Photodisruption of ocular tissue using light energy emitted by a Nd: Y AG laser, including discission of the posterior capsule of the eye (posterior capsulotomy) iridectorny, and selective laser trabeculoplasty. · Selecta LED Trio or Digital Trio: Photodisruption of ocular tissue using light energy emitted by a Nd: Y AG laser, including discission of the posterior capsule of the eye (posterior capsulotomy) iridectorny, selective laser trabeculoplasty, and retinal photocoagulation.
    Device Description
    The Selecta Duet LED and Digital Duet subject devices are each a fully integrated, highperformance diagnostic slit lamp and therapeutic laser delivery system. The diagnostic slit lamp is for examining the anterior segment of the eye, from the corneal epithelium to the posterior capsule. The integrated Nd:YAG Q-Switch laser module provides short pulses at the wavelength corresponding with the selected operating mode. Two modes are available: PD (YAG) mode: 1064 nm for photodisruption (PD) of ocular tissues in procedures such as posterior capsulotomy, iridotomy, and iridectomy, and SLT mode: 532 nm for Selective Laser Trabeculoplasty (SLT). The Selecta LED Trio and Digital Trio subject devices are each created by connecting the Selecta LED Duet and Digital Duet, respectively, to a compatible, FDA-cleared, Lumenis continuous 532 nm wavelength photocoagulator laser, via the LaserLink S. When the user connects the Duet to the LaserLink S, the Duet-part acts only as a Slit Lamp since the integrated Duet-laser is disabled and the laser in the external photocoagulator takes over. This combination adds the ability to perform retinal photocoagulation, as well as other indications cleared for the continuous 532 nm wavelength photocoagulator laser. The user disconnects the Duet from the LaserLink S for the system to perform as a Duet.
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