Get Erchonia Corporation - Accessdata Fda

This guide provides a comprehensive overview of how to fill out the Erchonia Corporation - Accessdata Fda form online. Whether you are familiar with regulatory documents or filling out forms for the first time, this step-by-step approach will assist you in completing the process accurately.

Follow the steps to successfully complete your form.

1. Click the ‘Get Form’ button to obtain the form and access it in the interface.
2. Enter the 510(k) Number if you know it; in this case, the correct number is K142042.
3. Fill in the 'Device Name' field with 'Erchonia® SHL' as indicated.
4. In the 'Indications for Use' section, provide a description that states the Erchonia® SHL Laser is for non-invasive aesthetics to reduce circumference in specific body areas for individuals with a Body Mass Index (BMI) between 30 kg/m² and 40 kg/m².
5. Select the appropriate type of use based on your need. You may choose 'Prescription Use' or 'Over-The-Counter Use' as applicable.
6. Continue additional details on a separate page if needed, but do not write below the designated line.
7. After completing the form, review all entries for accuracy before proceeding to save, download, print, or share your completed form.

Complete your documents online to ensure a smooth submission process.