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510(k) Data Aggregation

    K Number
    K972028
    Device Name
    DERMASCAN SURGICAL LASER SCANNER
    Manufacturer
    ESC MEDICAL SYSTEMS LTD.
    Date Cleared
    1997-10-24

    (144 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K964684,K962242
    Why did this record match?
    Device Name :

    DERMASCAN SURGICAL LASER SCANNER

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

    The DermaScan™ Surgical Laser Scanner is intended for use in soft tissue ablation procedures.

    Device Description

    DermaScan™ Surgical Laser Scanner is a microprocessor controlled device that converts a surgical laser device into an advanced aesthetic surgery tool for a variety of cosmetic procedures. The device uses motorized mirrors to deflect a laser beam over a specified area in a uniform and controlled manner. Using a sophisticated interface the user can specify a large number of parameters to achieve a scanning procedure that is tailored to the individual needs of the patient. The scanner then controls the actual tissue ablation process to achieve a uniform removal of tissue over the entire area. An aiming beam is used to outline the treated area

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification for the DermaScan™ Surgical Laser Scanner. This document does not describe acceptance criteria or a study proving the device meets acceptance criteria.

    Instead, it's a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, primarily focusing on device description, intended use, and comparison to existing products. It explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None," indicating that no performance studies were conducted or submitted for this device.

    Therefore, I cannot provide the requested information from this document. The sections on acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and MRMC studies are not present.

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