LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K140471
    Device Name
    PRO X OTC 5
    Manufacturer
    LA LUMIERE, LLC
    Date Cleared
    2015-01-15

    (324 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K120775,K123999
    Why did this record match?
    Device Name :

    PRO X OTC 5

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

    The Pro X OTC 5 is an Over-The-Counter device intended for use in the treatment of facial wrinkles. It is for people with wrinkles on their face and who have Fitzpatrick skin types I, II and/or III.

    Device Description

    The Pro X OTC 5 is an Over-the-Counter device intended for use in the treatment of facial wrinkles. Facial wrinkles are lines on the skin that appear as you age. Facial wrinkles can appear anywhere on the face, such as on the forehead, around the eyes, and by the mouth. The Pro X OTC 5 is for people with wrinkles on their face and who have Fitzpatrick skin types I, II, and/or III.

    The Pro X OTC 5 uses known LED light therapy technology. A combination of red light (620-630mm) and infrared light (855nm) is emitted. To use the Pro X OTC 5 device, users place the lightweight mask over the face and then press the "On" button on the controller to start treatment. The device will automatically turn off after each treatment cycle.

    The Pro X OTC 5 device is designed to be used for 30 treatment sessions. The full treatment regimen for facial wrinkles includes 60 individual treatments, therefore purchase of two (2) devices is needed to receive the full treatment regimen.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

    Device Name: Pro X OTC 5 Light Therapy Device
    Intended Use: Treatment of facial wrinkles in people with Fitzpatrick skin types I, II, and/or III.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined "acceptance criteria" with numerical thresholds for clinical performance. Instead, it aims to demonstrate substantial equivalence to predicate devices and effectiveness through a clinical study. The primary measure of effectiveness is improvement in Fitzpatrick Wrinkle and Elastosis Scale scores.

    Acceptance Criteria (Implied)Reported Device Performance
    Clinical Effectiveness:
    Improvement in facial wrinkles (as measured by Fitzpatrick Wrinkle and Elastosis Scale).Treatment Group (n=30):
    Physician 1:
    - Baseline mean grade: 5.10
    - 8-week mean grade: 3.86 (1.24 point improvement)
    - 20-week post-treatment mean grade: 3.83 (1.28 point improvement from baseline)
    Physician 2:
    - Baseline mean grade: 5.03
    - 8-week mean grade: 3.83 (1.21 point improvement)
    - 20-week post-treatment mean grade: 3.90 (1.14 point improvement from baseline)
    Individual Improvement: Each subject in the treatment group demonstrated at least 1 point improvement (baseline vs. 20-weeks post-treatment).
    Statistical Significance: Treatment Group showed statistically significant improvement (p
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1