Get the free 510(k) Summary for LC Therapy, Model LCT-1000 Laser - accessdata fda

This document provides a summary of the safety and effectiveness of the LiteCure, LLC. LC Therapy, Model LCT-1000 laser device, including its intended use, technological characteristics, and substantial

How to fill out 510k summary for lc

How to fill out 510(k) Summary for LC Therapy, Model LCT-1000 Laser

1. Identify the intended use and indications for the LC Therapy, Model LCT-1000 Laser.
2. Gather all relevant clinical and non-clinical data supporting the safety and effectiveness of the device.
3. Provide a detailed description of the device, including design features and operational principles.
4. Include the labeling and promotional materials that will accompany the device.
5. Summarize the substantial equivalence to a predicate device, highlighting similarities and differences.
6. Complete the special 510(k) requirements for software, if applicable.
7. Compile a table of contents for the summary and ensure all sections are clearly labeled.

Who needs 510(k) Summary for LC Therapy, Model LCT-1000 Laser?

1. Manufacturers seeking market clearance for the LC Therapy, Model LCT-1000 Laser.
2. Medical device companies complying with FDA regulations for laser therapy devices.
3. Healthcare providers interested in using or distributing the LC Therapy, Model LCT-1000 Laser.

For pdfFiller’s FAQs

What is 510(k) Summary for LC Therapy, Model LCT-1000 Laser?

The 510(k) Summary is a document submitted to the FDA that outlines details about the LC Therapy, Model LCT-1000 Laser, demonstrating that it is substantially equivalent to a legally marketed device. It includes information on the device's intended use, technological characteristics, and any performance data.

Who is required to file 510(k) Summary for LC Therapy, Model LCT-1000 Laser?

The manufacturer or the entity responsible for marketing the LC Therapy, Model LCT-1000 Laser is required to file the 510(k) Summary with the FDA before the device can be marketed.

How to fill out 510(k) Summary for LC Therapy, Model LCT-1000 Laser?

To fill out the 510(k) Summary, include information such as the applicant's details, device description, intended use, and substantial equivalence justification. Follow the FDA's guidelines and format requirements, ensuring to provide necessary supporting data and references.

What is the purpose of 510(k) Summary for LC Therapy, Model LCT-1000 Laser?

The purpose of the 510(k) Summary is to provide the FDA with sufficient information to assess whether the LC Therapy, Model LCT-1000 Laser is safe and effective for its intended use, confirming its substantial equivalence to an existing device.

What information must be reported on 510(k) Summary for LC Therapy, Model LCT-1000 Laser?

The 510(k) Summary must include the device's name, intended use, description, labeling, performance data, technological characteristics, and a comparison to predicate devices, among other relevant information.