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510(k) Data Aggregation

    K Number
    K081219
    Date Cleared
    2008-06-30

    (61 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    APOLLO MINI IPL SYSTEM

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

    The Apollo Mini-IPL System is indicated for use skin types I-IV according to the Fitzpatrick Scale for the following indications: Hair Removal (650nm filter), Permanent hair reduction (650nm filter), Treatment of vascular lesions (510nm filter), Treatment of benign pigmented lesions (510nm filter), Mild to Moderate inflammatory acne (450nm filter).

    Device Description

    The Apollo Mini IPL System delivers pulsed light at wavelengths starting at 450-1200nm nanometers. The device consists of the cabinet, which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide.

    AI/ML Overview

    The provided text is a 510(k) Summary for the Apollo Mini IPL System. This document outlines the device's intended use and claims substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria.

    The "Performance Data" and "Results of Clinical Study" sections explicitly state "None." This means that Sandstone Medical Technologies, LLC did not submit performance data or clinical study results with their 510(k) application to demonstrate the Apollo Mini IPL System met specific acceptance criteria. Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices.

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device's performance based on the input text.

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