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510(k) Data Aggregation

    K Number
    K173157
    Device Name
    Dr's Light2
    Manufacturer
    Good Doctors Co.,Ltd.
    Date Cleared
    2018-05-29

    (242 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Dr's Light2

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

    Dr's Light 2 is a hand held LED polymerization light intended to cure dental composites using visible light.

    Device Description

    Not Found

    AI/ML Overview

    This document, K173157, is a 510(k) premarket notification for a dental device called "Dr.'s Light 2." It is a regulatory approval letter from the FDA. Based on the provided text, there is no information about acceptance criteria for a study, performance metrics, sample sizes, expert qualifications, or any details related to an AI/algorithm-based medical device study.

    The document states that the device is a "hand held LED polymerization light intended to cure dental composites using visible light." This is a physical, light-emitting device, not a software or AI-driven diagnostic or analytical tool that would typically involve the kind of studies you are asking about (e.g., MRMC, standalone algorithm performance, ground truth establishment through expert consensus or pathology).

    Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them, as the provided input does not contain any of that information. The document is solely an FDA clearance letter for a non-AI dental light.

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