LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K101382
    Device Name
    DPL NUVE
    Manufacturer
    LED TECHNOLOGIES, LLC
    Date Cleared
    2010-11-09

    (176 days)

    Product Code
    OHS,GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K141181
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Indicated as an over-the-counter phototherapy device for the treatment of mild to moderate acne.

    Device Description

    The dpl® Nüve is a lightweight, handheld, light emitting diode (LED) device with interchangeable heads which emit light energy. A blue LED head in the 415 nm spectrum is used in treatment for mild to moderate inflammatory acne. A red head at 625 nm and a purple head (infrared) in the 830 nm spectrum are used in combination for reduction of periorbital wrinkles. The handle of the device contains the electronics of the device including a fan for cooling and an automatic shut-off safety feature

    AI/ML Overview

    The provided text does not contain information about acceptance criteria for the device's performance in treating periorbital wrinkles or acne, nor does it detail a study proving the device meets specific performance criteria.

    Instead, the document focuses on:

    1. Substantial Equivalence: The primary assertion is that the dpl® Nüve is "substantially equivalent in function and technology" to predicate devices (Omnilux New U for wrinkles and Tanda Skin Care for acne). This means the device is considered as safe and effective as existing legally marketed devices, rather than meeting specific quantifiable performance benchmarks detailed in the submission.
    2. Safety Testing: The device's safety is demonstrated by meeting general electrical safety standards (IEC 60601-1, EN 60601-1-2, EN 60601-2-22) and patient contact material safety (ISO 10993).
    3. Intended Use/Indications for Use: These describe the therapeutic areas the device is cleared for (periorbital wrinkles and mild to moderate acne).

    Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and performance study details based on the provided text. The document does not describe a clinical study with quantifiable performance metrics, sample sizes, expert ground truth, or an MRMC study.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1