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510(k) Data Aggregation

    K Number
    K193464

    Validate with FDA (Live)

    Device Name
    ND:YAG Laser
    Manufacturer
    Beijing Superlaser Technology Co., Ltd.
    Date Cleared
    2020-04-13

    (119 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K161926
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ND: YAG Laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and the removal of black or blue tattoos.

    Device Description

    The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm.

    The device is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos. It is for prescription use only.

    AI/ML Overview

    This document is a 510(k) Pre-market Notification for a medical device called the "ND:YAG Laser" (Model SL-NY602) from Beijing Superlaser Technology Co., Ltd. It seeks to demonstrate substantial equivalence to a predicate device, the "ND YAG Q-switch Laser Therapy Machine" (K161926) from Beijing ADSS Development Co., Ltd.

    Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

    1. Table of Acceptance Criteria and Reported Device Performance

    Strictly speaking, this document does not present "acceptance criteria" in the traditional sense of specific performance metrics with defined thresholds for sensitivity, specificity, accuracy, etc. Instead, it aims to demonstrate substantial equivalence (SE) based on comparative tables for general, technical, and safety aspects. The "acceptance criteria" for this type of submission are that the proposed device is as safe and effective as the predicate device. The reported performance is implicitly the device meeting the described characteristics.

    Criterion/MetricPredicated Device K161926 Performance (Implied Acceptance)Proposed Device ND:YAG Laser PerformanceRemark
    General
    Product CodeGEXGEXSE
    Regulation No.21 CFR 878.481021 CFR 878.4810SE
    Class22SE
    Where usedhospitalhospitalSE
    Intended UseTreatment of benign cutaneous lesions (Warts, Scars, Striae, Psoriasis), benign pigmented lesions (Lentigines, Nevus, Birthmark), and removal of black or blue tattoos.Treatment of benign cutaneous lesions (Warts, Scars, Striae, Psoriasis), benign pigmented lesions (Lentigines, Nevus, Birthmark), and removal of black or blue tattoos.SE
    Technical
    Laser MediumNd:YAGNd:YAGSAME
    Wavelength1064 nm, 532 nm1064 nm, 532 nmSAME
    Output energy100-1000mJ (1064nm), 50-500mJ (532nm)100-1000mJ (1064nm), 50-500mJ (532nm)SAME
    Max. Energy Density31.8J/cm2, 15.9 J/cm231.8J/cm2, 15.9 J/cm2SAME
    Spot Size2-10mm2-10mmSAME
    Pulse Width5ns-8ns5ns-8nsDIFFERENT
    Frequency1-10 Hz1-10 HzSAME
    DisinfectionDisinfect handpiece by 75% medicinal alcoholWipe outer surface with 70% alcohol and non-abrasive medical grade anti-bacterialSIMILAR (both relate to cleaning/disinfection methods for safety)
    Laser ClassClass 4Class 4SAME
    Aiming BeamRed Laser, <6mWRed (650nm) laser, ≤5mWSAME
    Safety
    Electrical SafetyComply with IEC 60601-1, IEC 60601-2-22Comply with IEC 60601-1, IEC 60601-2-22SE
    EMCComply with IEC 60601-1-2Comply with IEC 60601-1-2SE
    Laser SafetyComply with IEC 60601-2-22, IEC 60825Comply with IEC 60601-2-22, IEC 60825SE

    2. Sample Size used for the Test Set and the Data Provenance

    The submission does not rely on a test set of patient data for clinical performance evaluation. Instead, it relies on demonstrating equivalence through comparison to a legally marketed predicate device and non-clinical testing.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

    Not applicable. No ground truth was established by experts for a clinical test set in this 510(k) submission.

    4. Adjudication Method for the Test Set

    Not applicable. There was no clinical test set requiring adjudication in this submission.

    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 is a laser device, not an AI-assisted diagnostic or imaging system, so an MRMC study is not relevant.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Not applicable. This is a laser device, not an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    Not applicable. Clinical ground truth (e.g., pathology, outcomes data) was not used in this 510(k) submission. The "ground truth" for demonstrating substantial equivalence relied on established safety and performance standards for similar laser devices and the characteristics of the predicate device.

    8. The sample size for the training set

    Not applicable. This is a hardware medical device (laser system), not a machine learning algorithm that requires a training set.

    9. How the ground truth for the training set was established

    Not applicable, as there is no training set for this type of device.

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