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510(k) Data Aggregation

    K Number
    K232656
    Device Name
    BLU TOTALE (Model: ENEOB852)
    Manufacturer
    Premier North America Inc.
    Date Cleared
    2023-11-14

    (75 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K172555
    Why did this record match?
    Reference Devices :

    K172555

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

    BLU TOTALE is an over the counter phototherapy device for use in dermatology for the treatment of mild to moderate acne.

    Device Description

    BLU TOTALE is a battery-operated device that uses low power light spectrum at blue LED, at wavelength of 415 ±15nm emitting optical power in a uniform distribution with no hot spots. It is a hand held light emitting diode (LED) device for the treatment of acne designed for home-use.

    AI/ML Overview

    The provided text is a 510(k) summary for the BLU TOTALE device (Model: ENEOB852), an over-the-counter phototherapy device for treating mild to moderate acne. This document describes the device, its intended use, and its substantial equivalence to a predicate device (Sapphire, K172555).

    However, the document does not contain any information regarding acceptance criteria, performance studies (clinical or otherwise), sample sizes, ground truth establishment, or expert involvement related to demonstrating the device's efficacy for treating acne. The "Non-clinical Testing" section only lists various safety and performance bench tests conducted to conform to international standards (e.g., electrical safety, EMC, biocompatibility, photobiological safety), and does not report on clinical efficacy.

    Therefore,Based on the provided text, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because:

    1. No clinical efficacy acceptance criteria or corresponding performance claims are present. The document focuses on demonstrating substantial equivalence to a predicate device through shared specifications and conformance to safety and electrical standards. There are no tables of acceptance criteria for treatment efficacy or reported clinical performance metrics in the provided text.

    2. No study proving clinical efficacy is described. The "Non-clinical Testing" section details laboratory bench tests for safety (electrical, EMC, photobiological, biocompatibility) and basic device performance (pyrogen, skin temperature, LED wavelength/power density). It does not describe any study (retrospective, prospective, standalone, or MRMC) that evaluates the device's effectiveness in treating acne on human subjects.

    Without information on a clinical study or stated performance criteria related to the device's indicated use for acne treatment, it is impossible to answer the specific questions below.

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