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510(k) Data Aggregation

    K Number
    K121920
    Device Name
    LASERBRUSH
    Manufacturer
    SUNETICS INTERNATIONAL MARKETING GROUP, LLC
    Date Cleared
    2013-06-27

    (360 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K110233,K103368,K112524
    Why did this record match?
    Device Name :

    LASERBRUSH

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

    The Sunetics LaserBrush is indicated to treat Androgenetic Alopecia, promote hair growth and prevent further hair loss in males who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV & also in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss & Fitzpatrick Skin Types I to IV.

    Device Description

    The Sunetics LaserBrush consists of a handheld low-level laser device intended to promote hair growth. Depending upon the Sunetics LaserBrush model, the device provides distributed laser light using seven (7), nine (9), or twelve (12), collimated, 650 nm,

    AI/ML Overview

    The provided 510(k) submission for the Sunetics LaserBrush does not include a study demonstrating device performance against specific acceptance criteria relevant to an AI/ML medical device. The submission focuses on substantial equivalence to a predicate device (HairMax LaserCombs) through comparison of technological characteristics.

    Therefore, the following information is not present in the provided text:

    • A table of acceptance criteria and reported device performance (in the context of AI/ML performance metrics).
    • Sample size for the test set or data provenance for an AI/ML study.
    • Number of experts or their qualifications for establishing ground truth for an AI/ML study.
    • Adjudication method for an AI/ML study.
    • Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done or its effect size.
    • Whether a standalone (algorithm only) performance study was done.
    • The type of ground truth used for an AI/ML study.
    • Sample size for the training set for an AI/ML model.
    • How ground truth for the training set was established for an AI/ML model.

    What is provided regarding performance:

    The submission states under "Performance Data":
    "The laser wavelength, average and peak power levels, laser treatment field and energy delivery of the Sunetics LaserBrush and the Lexington Hairmax LaserComb were substantially equivalent."

    And in the "Conclusions":
    "The performance data discussed above demonstrate that the Sunetics LaserBrush device is as safe and effective as the predicate device."

    This indicates that the "performance data" refers to the physical and operational characteristics of the laser device being comparable to the predicate, rather than clinical efficacy data generated from a new trial or AI/ML performance metrics. The FDA's 510(k) clearance confirms substantial equivalence based on these comparisons.

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