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510(k) Data Aggregation

    K Number
    K200118
    Device Name
    Diode Laser Therapy Device
    Manufacturer
    Shanghai Apolo Medical Technology Co., Ltd.
    Date Cleared
    2020-04-17

    (87 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K172193
    Why did this record match?
    Reference Devices :

    K172193

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

    The Diode Laser Therapy Device is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.

    Device Description

    The Diode Laser Therapy Devices is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective photothermolysis. The wavelength of 810nm, 755, and 1064nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system. The proposed device includes power supply system, delivery system, control system, cooling system, laser system. The 755nm, 810nm, 1064nm handpieces with different treatment size are available for different models.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a Diode Laser Therapy Device. However, it explicitly states "VIII Clinical Testing: It is not applicable." Therefore, the document does not contain information about clinical studies with acceptance criteria, sample sizes, expert ground truth establishment, MRMC studies, or standalone performance for an AI/CADe device.

    The information you are requesting typically applies to the clinical evaluation of AI/CADe devices, often involving extensive human reader studies and ground truthing. This document is for a laser therapy device, and its clearance process does not involve such studies for proving device performance in the same way an AI/CADe device would.

    Therefore, I cannot populate the table or answer the questions related to acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on non-clinical testing (electrical safety, electromagnetic compatibility, biocompatibility) to demonstrate substantial equivalence to a predicate device.

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