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510(k) Data Aggregation

    K Number
    K082040
    Device Name
    MINISILK FT
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING SPA
    Date Cleared
    2009-08-27

    (405 days)

    Product Code
    ONF
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K031258
    Why did this record match?
    Device Name :

    MINISILK FT

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

    The Minisilk FT pulsed light device is indicated for permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels and treatment of benign pigmented lesions.

    Device Description

    The Minisilk_FT is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200 nm. Emission activation is by footswitch. Overall weight of the system is 16 kg, and the size is 22x37x45 cm (H x W x D). Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.

    AI/ML Overview

    This 510(k) summary explicitly states: "Nonclinical Performance Data: None; Clinical Performance Data: None."

    Therefore, based on the provided document, the following information regarding acceptance criteria and a study to prove the device meets them cannot be detailed:

    1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided.
    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable as no clinical study was conducted.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable as no clinical study was conducted.
    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical study was conducted.
    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document describes a pulsed light system, not an AI-assisted diagnostic device.
    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document describes a pulsed light system, not an algorithm.
    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical study was conducted.
    8. The sample size for the training set: Not applicable as no clinical study was conducted, and the device is not an AI algorithm requiring a training set.
    9. How the ground truth for the training set was established: Not applicable.
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