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This document provides a summary of the 510(k) notification process for the Glow by EndyMed device, detailing its intended use, device description, predicate devices, and compliance with performance

How to fill out 510k summary for glow

How to fill out 510(k) Summary for Glow by EndyMed

1. Gather the necessary information about the Glow device, including its intended use and technological characteristics.
2. Review the requirements set by the FDA for a 510(k) summary to ensure compliance.
3. Identify the predicate device that the Glow device is being compared to in the 510(k) submission.
4. Clearly describe the device and its components, including materials and manufacturing processes.
5. Detail the performance testing and data supporting the device's safety and effectiveness.
6. Summarize the risk assessment and mitigation measures taken during the device's development.
7. Provide any labeling information needed for users and practitioners.
8. Submit the completed 510(k) summary along with any required documentation to the FDA.

Who needs 510(k) Summary for Glow by EndyMed?

1. Manufacturers of the Glow by EndyMed who wish to market their medical device in the United States.
2. Healthcare professionals seeking to understand the regulatory status and safety data of the Glow device.
3. Research and development teams involved in the device's design and compliance with FDA regulations.

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Ultherapy® is an FDA-approved treatment that uses a high-intensity, focused ultrasound to reach the deep structures of the face to lift and tighten.

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Common side effects include mild redness, swelling, and sensitivity in the treated area, which generally subside within a few days. It's crucial to follow post-treatment care instructions provided by the skincare professional to ensure proper healing and optimal results.

For pdfFiller’s FAQs

What is 510(k) Summary for Glow by EndyMed?

The 510(k) Summary for Glow by EndyMed is a premarket submission to the FDA demonstrating that the Glow device is safe and effective, and is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary for Glow by EndyMed?

The manufacturer or company that produces the Glow by EndyMed device is required to file the 510(k) Summary with the FDA.

How to fill out 510(k) Summary for Glow by EndyMed?

To fill out the 510(k) Summary for Glow by EndyMed, the manufacturer must compile information including the device description, indications for use, technological characteristics, and data demonstrating substantial equivalence.

What is the purpose of 510(k) Summary for Glow by EndyMed?

The purpose of the 510(k) Summary for Glow by EndyMed is to inform the FDA and the public about the device's safety and effectiveness and to obtain clearance to market the device.

What information must be reported on 510(k) Summary for Glow by EndyMed?

The 510(k) Summary must include device identification, a statement of intended use, performance testing data, labeling information, and comparisons with the predicate device.