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510(k) Data Aggregation

    K Number
    K072564
    Device Name
    ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM
    Manufacturer
    ALMA LASERS LTD.
    Date Cleared
    2008-05-23

    (255 days)

    Product Code
    GEX,FTC,HHR,LNK
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K033946,K051428,K060448,K030342,K024093,K020839,K041086,K033549,K032460,K050679,K003614,K053628,K030186,K052324,K042630,K982546,K041879,K043429,K033176,K033172,K023954
    Why did this record match?
    Device Name :

    ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Alma Lasers Harmony XL™ Multi-Application Platform is intended for use in dermatologic and general surgical procedures. The Harmony XL™ Multi-Application Platform is intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.

    Device Description

    The Alma Lasers Harmony XL™ Multi-Application Platform is comprised of the following main components: The main console unit that incorporates the touch-screen control panel, power supply modules, cooling system, switching module, service panel and isolating transformer. Variety of handpieces and attachment accessories. Footswitch.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the Harmony XL™ Multi-Application Platform, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting performance criteria and a study to meet them.

    The text outlines:

    • General information about the device and submitter.
    • A list of predicate devices.
    • A product description.
    • Extensive indications for use for various modules and handpieces in dermatologic and general surgical procedures.
    • A rationale for substantial equivalence.
    • A conclusion of substantial equivalence.

    It does not contain details regarding:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for any test set.
    3. Number or qualifications of experts for ground truth establishment.
    4. Adjudication methods.
    5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
    6. Standalone algorithm performance.
    7. Type of ground truth used in a study.
    8. Sample size for a training set.
    9. How ground truth for a training set was established.

    This document is a regulatory submission for substantial equivalence, not a scientific publication detailing performance studies against specific acceptance criteria.

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